2.

1 Required Activities and Documentation

All personnel must receive direct and detailed training for the performance of all duties and tasks that they perform. Competency assessments must be conducted and recorded for all components of the employees training and functional responsibilities upon completion of initial training. A clinical laboratory continuing education program that is adequate to meet the needs of all personnel must be documented, and evidence of ongoing adherence by all laboratory personnel must be readily available. A testing laboratory must have the following documents stored in the laboratory or readily available for authorized personnel: Organizational, departmental, and/or personnel policies that address such topics as orientation, training, continuing education requirements, performance evaluations, benefits, discipline, dress codes, holidays, security, communication, termination, and attendance [10-12]; job descriptions that define qualifications and delegation of duties for all laboratory positions [11-13]; personnel files that document each employees qualifications, training, and competency assessments as they relate to job performance [14]; and the organizational chart(s) that represent the formal reporting and communication relationships that exist among personnel and management and between the main laboratory unit and satellite units [15].

Standards for Laboratory Equipment

Proper maintenance of all laboratory equipment is necessary for assays to function within manufacturers specifications. Internal preventative maintenance activities as well as vendor provided maintenance/repair for laboratory equipment is paramount in providing accurate and reliable results. The standards below provide direction on how to accomplish this. Laboratory staff must conduct preventive maintenance and service per manufacturer specifications by following documented daily, weekly, and/or monthly routine maintenance plans for all equipment utilized to ensure that all equipment performs consistently and reproducibly during the conduct of the trial [20]. Additionally, the laboratory must document all scheduled preventive maintenance, unscheduled maintenance, service records, and calibrations for all equipment utilized. This documentation should be readily accessible to operators [20-22]. As a follow-up step, the laboratory director or designee must consistently review, sign, and date all documentation at least monthly to establish an audit trail [11,12]. The laboratory must establish tolerance limits for equipment temperatures and other monitored conditions (e.g., % CO2, liquid nitrogen levels) that are consistent with manufacturers guidelines and procedural activities because certain reagents and equipment perform optimally under specific conditions [23]. The lab should also maintain daily (or dates of use) record of temperatures and other monitored conditions (e.g. humidity). For observations that fall outside of designated tolerance ranges, the laboratory must maintain appropriate documentation of corrective action for these out-of-range temperatures and other condition
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Guidelines on Good Clinical Laboratory Practice

1 Introduction
The Good Clinical Laboratory Practices (GCLP) concept possesses a unique quality, as it embraces both the research and the clinical aspects of GLP. The development of GCLP standards encompasses applicable portions of 21 CFR parts 58 (GLP) [1] and 42 CFR part 493 (Clinical Laboratory Improvement Amendments -CLIA) [2]. Due to the ambiguity of some parts of the CFR regulations, the GCLP standards are described by merging guidance from regulatory authorities as well as other organizations and accrediting bodies, such as the College of American Pathologists (CAP), and the International Organization for Standardization 15189 (ISO) [3]. The British Association of Research Quality Assurance (BARQA) took a similar approach by combining Good Clinical Practice (GCP) and GLP in 2003 [4]. The GCLP standards were developed with the objective of providing a single, unified document that encompasses IND sponsor requirements to guide the conduct of laboratory testing for human clinical trials. Examples of these types of tests include protocol-mandated safety assays such as diagnosis of HIV-1 infection, blood processing to obtain high quality specimens routinely [5], and cellular and serological immunogenicity assays (e.g., enumeration of antigen-specific cells by ELISpot [6] or flow cytometry [7]), or enzyme-linked immunosorbent assays (ELISA) [8] to support clinical trials on a product licensure pathway. The intent of GCLP guidance is that when laboratories adhere to this process, it ensures the quality and integrity of data, allows accurate reconstruction of experiments, monitors data quality and allows comparison of test results regardless of performance location. In this paper, we expand the existing knowledge on GCLP standards based on GCP and GLP [4] and included elements of CAP, CLIA, and ISO to enhance and provide implementation guidance for the GLP requirements. A comprehensive version of the GCLP standards with accompanying templates and examples is available at [http://www3.niaid.nih.gov/research/resources/DAIDSClinRsrch/PDF/labs/GCLP.pdf] [9]. To illustrate the need for a single unified GCLP standards document, Table 1 compares major elements of US, UK and other international guidance documents, showing current gaps. The GCLP core elements described in this paper include: organization and personnel; laboratory equipment; testing facility operations; quality control program; verification of performance specifications; records and reports; physical facilities; specimen transport and management; personnel safety; laboratory information systems and quality management. By recognizing these standards as the minimum requirements for optimal laboratory operations, the expectation is that GCLP compliance will ensure that consistent, reproducible, auditable, and reliable laboratory

results from clinical trials can be generated for clinical trials implemented at multiple sites. A corollary of this infrastructure is that the data will be produced in an environment conducive to study reconstruction, enable prioritization between candidate product regimens and guide rationale decision making for moving products forward into advanced clinical trials.

2 Standards for Organization and Personnel

Appropriately trained and well organized laboratory staff are key to the successful operation of a research facility. Systems are required to drive organizational structure, training and ongoing competency assessment to ensure appropriate accountability and communication during study conduct.

2.1 Required Activities and Documentation

All personnel must receive direct and detailed training for the performance of all duties and tasks that they perform. Competency assessments must be conducted and recorded for all components of the employees training and functional responsibilities upon completion of initial training. A clinical laboratory continuing education program that is adequate to meet the needs of all personnel must be documented, and evidence of ongoing adherence by all laboratory personnel must be readily available. A testing laboratory must have the following documents stored in the laboratory or readily available for authorized personnel: Organizational, departmental, and/or personnel policies that address such topics as orientation, training, continuing education requirements, performance evaluations, benefits, discipline, dress codes, holidays, security, communication, termination, and attendance [10-12]; job descriptions that define qualifications and delegation of duties for all laboratory positions [11-13]; personnel files that document each employees qualifications, training, and competency assessments as they relate to job performance [14]; and the organizational chart(s) that represent the formal reporting and communication relationships that exist among personnel and management and between the main laboratory unit and satellite units [15].

3 Standards for Laboratory Equipment

Proper maintenance of all laboratory equipment is necessary for assays to function within manufacturers specifications. Internal preventative maintenance activities as well as vendor provided maintenance/repair for laboratory equipment is paramount in providing accurate and reliable results. The standards below provide direction on how to accomplish this. Laboratory staff must conduct preventive maintenance and service per manufacturer specifications by following documented daily, weekly, and/or monthly routine maintenance plans for all equipment utilized to ensure that all equipment performs consistently and reproducibly during the conduct of the trial [20]. Additionally, the laboratory must document all scheduled preventive maintenance, unscheduled maintenance, service records, and calibrations for all equipment utilized. This documentation should be readily accessible to operators [20-22]. As a follow-up step, the laboratory director or designee must consistently review, sign, and date all documentation at least monthly to establish an audit trail [11,12]. The laboratory must establish

tolerance limits for equipment temperatures and other monitored conditions (e.g., % CO2, liquid nitrogen levels) that are consistent with manufacturers guidelines and procedural activities because certain reagents and equipment perform optimally under specific conditions [23]. The lab should also maintain daily (or dates of use) record of temperatures and other monitored conditions (e.g. humidity). For observations that fall outside of designated tolerance ranges, the laboratory must maintain appropriate documentation of corrective action for these out-of-range temperatures and other conditions.

4 Standards for Test Facility Operation

4.1 Standard Operating Procedures
Standard operating procedures (SOPs) are critical for maintaining consistent test performance. The laboratory must write SOPs for all laboratory activities to ensure the consistency, quality, and integrity of the generated data. Current SOPs must be readily available in the work areas and accessible to testing personnel [24]. The laboratory must write these SOPs in a manner and language that is appropriate to the laboratory personnel conducting the procedures. SOPs should also be written in a standard format, such as the format recommended by the Clinical and Laboratory Standards Institute (CLSI) [25]. All laboratory personnel must document and maintain verification that they have reviewed and understood all relevant SOPs so that there is evidence that all personnel are knowledgeable of appropriate laboratory SOPs [26]

Quality Control Logs

QC logs must document control results assayed with each test to determine the acceptability of the QC run and to aid in detection of shifts and trends in control data [28,30]. QC records must be readily available to the staff performing the test. Results of controls must be recorded or plotted in real time (e.g., Levy Jennings [LJ] charts or control charts) to readily detect a malfunction in the instrument or in the analytic system. Laboratory personnel who perform QC runs, record results, and plot data on graphs must record their initials, date, and time as testing is performed. QC records should contain detailed information to reconstruct establishment of ranges for each QC material used for monitoring analytic performance. Information should include, but is not limited to: Package insert (containing material name, manufacturer, concentration, lot numbers, etc.), opened dates, expiration dates, dates of testing, testing personnel, raw data, evaluation, approval, and other appropriate information. Laboratory supervisory personnel must regularly review, sign, and date QC records and corrective action logs at least monthly [11,12] QC record retention time periods established by the laboratory must meet or exceed the requirements set forth by the product sponsor and/or any applicable regulatory bodies such as the FDA [31].

5.6 Labeling of Quality Control Materials and Reagents

All QC materials and reagents currently in use must be prepared and stored as required by the manufacturer. If ambient temperature is indicated for storage or use, there must be documentation that the defined ambient temperature is maintained and that corrective action is taken when tolerance limits are exceeded [23]. All QC materials and reagents must be properly labeled for content and include storage requirements, date opened, prepared, or reconstituted by the laboratory, and the initials of personnel who prepared/reconstituted the QC material and reagents, and expiration date [23]. An expiration date must be assigned to QC materials and reagents that do not have a manufacturerprovided expiration date or an expiration date that changes upon reconstitution or use. The manufacturer should be consulted should this situation arise. (Exception: Microbiological organismsstorage and sub-culturing techniques will determine time of use) [32]. Deteriorated or outdated (expired) QC materials and reagents must not be used because this may jeopardize the quality of collected data [23].

5.7 Inventory Control

The laboratory must have an established documented inventory system to maintain an appropriate amount of working supplies and reagents and to prevent delays in testing of specimens due to lack of required reagents [20,33]. There must be evidence of a system which highlights the need to place supply orders, tracks orders (once placed), and defines alternate plans for delayed deliveries of supplies and recovery procedures for out-of-stock conditions (a system that details steps to ensure minimal lapse in ability to perform testing).

Standards for Records and Reports

The laboratory must define and maintain a system to provide and retain all clinical trial data records and reports for a period of time to troubleshoot potential problems, or if it is necessary to reconstruct the study for auditing purposes. These records may include specimen tracking forms, laboratory requisitions, chain-of-custody documents, laboratory reports, equipment service and maintenance records, and instrument printouts [31].

Standards for Physical Facilities

The environment in which laboratory testing is performed must be conducive to efficient operations that do not compromise the safety of the staff or the quality of the pre-analytical, analytical and post-analytical processes.

8.1 Required Activities and Documentation

The laboratory design must account for equipment placement, proper ventilation, and have a designated area for reagent storage as well as archiving of data in a secure fire-proof (preferred), fire-resistant, or fire-protected environment with access to only authorized personnel.

8.2 General Space

Laboratory work areas must have sufficient space so that there is no hindrance to the work or employee safety [45,46]. Laboratory room (ambient) temperature and humidity must be controlled so that equipment and testing is maintained within the tolerance limits set forth by the manufacturer [23]. Ambient temperature logs should be utilized to document the acceptable ambient temperature range, record daily actual temperatures, and allow for documentation of corrective action taken should the acceptable temperature ranges be exceeded [47]. All floors, walls, ceilings, and bench tops of the laboratory must be clean and well maintained [48].

Standards for Specimen Transport and Management

The accuracy of all laboratory test results depends on the identity and integrity of the specimen submitted. The establishment of a sound specimen chain of custody from collection through to reporting of test results is paramount in ensuring quality data.

9.1 Required Activities and Documentation

The laboratory must have documented procedures for collection, transportation, and receipt of specimens because the accuracy of all laboratory tests in dependant on specimen quality [23]. A laboratory can only ensure specimen integrity when following appropriate specimen management and transportation procedures. A properly completed request form must accompany each study-participant sample to the laboratory. The request form must document unique studyparticipant identifiers, specimen collection date and time, study participant demographics, specimen type, and the collectors (phlebotomists) identity [49]. The specimen inspection process must involve verification of the specimen container label information with the request form or log sheet [50]. Any discrepant or missing information must be verified promptly, before specimens are processed or stored by laboratory personnel. The laboratory must have documented Specimen Acceptance/ Rejection Criteria for evaluation of sample adequacy and integrity [24,51]. The laboratory must maintain an audit trail for every specimen from collection to disposal or storage. Audit trails must verify the date and time an activity was performed and the personnel responsible for that activity. All audit trails must be documented [51]. A shipping procedure must be documented that addresses preparing shipments by following all federal and local transportation of dangerous goods regulations (e.g., International Air Transport Association (IATA)) by laboratory personnel who are certified in hazardous materials/dangerous goods transportation safety regulations [52]. Twenty-four-hour monitoring of storage conditions (using personnel and/or electronic monitoring with alert systems) and SOPs for response to alerts must be in place to ensure the integrity of samples is maintained.
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10 Standards for Personnel Safety

The safety of all laboratory staff is paramount to avoid laboratory accidents that may jeopardize acquisition of infectious agents through handling of blood, as an example. Although exposure cannot always be avoided, every precaution must be taken to provide a safe work environment. V. Managers

A. Responsible for ensuring the overall quality assurance of their divisions, including: 1. reviewing data and identifying problems 2. recommending corrective action 3. prioritizing identified areas of concern 4. implementing a monitoring plan 5. implementing alternative corrective action if the solution identified for problems is ineffective 6. documenting all quality assessment activities. level of quality. VI. Terminology Acceptance Criteria/Limits: specified limits placed on characteristics of a quality control item as defined in required methods. These limits are either statistically defined by historical method performance or by specific method requirements. Accuracy: degree of agreement between an observed value and an accepted reference value. Accuracy includes a combination of random error (precision) and systematic error (bias) components due to sampling and analytical operations Analyst: designated individual who performs the analytical methods and associated techniques and who is responsible for applying required laboratory practices and other pertinent quality controls to meet the required level of quality. Bureau of Clinical Laboratories Quality Assessment Plan _______ ________ _ 3 Assessment: evaluation process used to measure or establish the performance, effectiveness, and conformance of an organization and/or its systems to defined criteria. Audit: systematic evaluation to determine the conformance to quantitative and qualitative specifications of some operational function or activity. Blank: sample that has not been exposed to the analyzed sample stream in order to monitor contamination during sampling, transport, storage or analysis. The blank is subjected to the usual analytical and measurement process to establish a zero baseline or background value. Blind Sample: sample for analysis with a composition known to the submitter. The analyst/laboratory may know the identity of the sample but not its composition. It is used to test the analysts or laboratorys proficiency in the execution of the measurement process. Calibration: determination, by measurement or comparison with a standard, of the correct value of each scale reading on a meter, instrument, or other device. The levels of the applied calibration standard should bracket the range of planned or expected sample measurements. Confirmation: verification of the identity of a component through the use of an approach with a different scientific principle from the original method. Corrective Action: action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent

recurrence. Deficiency: unauthorized deviation from acceptable procedures or practices, or a defect in an item. Document Control: act of ensuring that documents (and revisions thereto) are proposed, reviewed for accuracy, approved for release by authorized personnel, distributed properly and controlled to ensure use of the correct version at the location where the prescribed activity is performed. Precision: degree to which a set of observations or measurements of the same property, obtained under similar conditions, conform to themselves Proficiency Test (PT) Sample: a sample, the composition of which is unknown to the analyst and is provided to test whether the analyst/laboratory can produce analytical results within specified acceptance criteria. Quality Control Sample: sample used to assess the performance of all or a portion of the measurement system. Reference Material: material or substance, one or more properties of which are sufficiently well established, to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials. X. Laboratory Reagents A. Reagents are defined as any chemical substance used to dissolve, digest, extract, react with or otherwise interact with any sample or analytical component of the sample. B. Reagents used in the will be of the appropriate quality for their intended use. C. All reagents prepared by laboratory shall be marked with date of preparation and expiration date. D. All reagents purchased from a commercial vendor will be marked with the date of receipt. E. All reagents will be marked with date opened. F. All reagents will be labeled with the expiration date. G. All reagents shall be stored according to manufacturers instructions. H. All reagents shall be labeled to indicate content, and when appropriate titer or concentration. I. Reagent shelf life will be observed and must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. J. Components of reagent kits of different lot number are not interchangeable unless specified by the manufacturer. XIV. Quality Control (QC) Assessment A. QC is performed and documented for each procedure as recommended by the manufacturer and as described by the division procedure manual. B. QC is evaluated with each patient run to determine if the patient run is acceptable. C. QC data is charted each day of business or monthly, depending on the manufacturers directions, and observed for accuracy and precision of test procedures.

1. When problems occur, corrective action is taken and documented on the Monthly QA Audit Form (Appendix S-22). D. Calibrations are performed according to manufacturer's recommendations. Instruments that are internally calibrated by the manufacturer have their calibrations verified at least every six months. E. Preventive maintenance is performed according to manufacturer's recommendations for all instruments and equipment. F. Temperatures of room, refrigerators, incubators, and other temperature dependent equipment are recorded each day of business. Humidity checks, where applicable, are also recorded. G. Parallel (comparison) studies will be done on all analytes or tests performed on different instruments (ex: back-up systems) or performed by different methodologies, where applicable, and reviewed by the technical supervisor and division manager. The comparison studies are performed twice annually to verify the accuracy and reliability of those tests not included in an approved PT program. H. Remedial actions are taken when: 1. test methods fail, 2. test equipment fails, 3. media/reagents fail, 4. patient results are outside the reportable range, 5. a population reference range is inappropriate, 6. controls are out of range, 7. calibration is unacceptable, 8. established time frames cannot be met, 9. reported results are incorrect. XVI. Communication Problems and Complaints A. Communication problems 1. An assessment of any problem occurring due to a breakdown in communication between the laboratory and the health care provider is investigated and documented. 2. Remedial action is documented. 3. The QA Committee will review the complaints, corrective actions and documents. B. Complaints 1. Complaints/ problems received by any employee from staff, patients, or health care providers are documented in telephone logs, complaint logs, the "Documentation of Communication Breakdown or Complaints" form (Appendix S-25), or the Problem/Complaint/Remedial Action Form (Appendix S-26). 2. The remedial action is documented for all valid complaints. 3. When corrective actions are necessary to decrease problems with a procedure (pre-analytical, analytical, or post-analytical), the effectiveness of them are reviewed by the division manager. XVIII. Appendices

S-1 Outcome-Oriented Survey S-2 Quality Assessment Committee Members S-3 Laboratory Personnel Qualifications S-4 Employee Orientation Checklist S-5 Employee Training Report S-6 Employee Competency Checklist S-7 Employee Medical Information Card S-8 Policy Acknowledgement Form S-9 Policy Bureau of Clinical Laboratories Quality Assessment Plan _______ ________ __________________ ____ S-1 Outcome-Oriented Survey

CLINICAL LABORATORY ADMINISTRATOR, #X40 BASIC PURPOSE: Positions within this job family are assigned responsibilities for the overall management and supervision of a staff of technical and support personnel who perform clinical laboratory examinations or for directing the activities of a comprehensive statewide laboratory system providing diagnostic epidemiological and scientific services to state residents. TYPICAL FUNCTIONS: The functions within this job family will vary by level, but may include the following:

Plans, organizes, directs and coordinates a statewide clinical laboratory service. Develops and establishes laboratory goals, policies, programs and plans. Appraises needs for laboratory services; develops new, additional or different laboratory service programs. Coordinates and integrates laboratory activities with those of other subdivisions and with other state agencies conducting programs that require support from the clinical laboratories. Participates in the development of new programs, methodologies, tests and products necessary to further the departments commitment to prevention and control of disease. Supervises the preparation and maintenance of laboratory records and reports; summarizes laboratory activities, accomplishments and needs. Develops and implements policies, procedures and performance standards designed to ensure efficient laboratory operation. Interprets or verifies difficult or unusual analyses; plans and supervises the performance of special tests and projects. Consults with physicians, hospital personnel and independent and hospital laboratory personnel regarding common laboratory problems. Plans new laboratory facilities; requisitions new equipment and laboratory supplies; determines and recommends laboratory support for departmental programs and activities. Represents the department in court or at hearings as an expert witness and public contacts, reviews, comments, and interprets federal, state legislation and local laws, objective, rules and procedures affecting the operation of laboratories. Cooperates with local, state and national agencies and organizations for the improvement of laboratory services particularly in reference to public health and medical services. Supervisory Function - Due to the unprecedented growth of the Lab (1000% increase in intake and outgo), I am now supervising two full-time and three or more part-time nontechnical staff, all of whom are assisting me in performing office functions. Administrative Responsibilities - I authorize bids and quotes for potential customers, perform contract negotiations and approve such contracts, in each case proceeding with these negotiations to completion. Responsibility for Scheduling Technicians' Workloads - I attempt to hold regular staff meetings with all technicians. Purpose of these meetings is to discuss workloads, schedule timing for analyses, and to rearrange schedules as required by clients' needs. It

has become necessary for me to do this because of the frequent business absences (approximately 25% of the time) of the lab manager as he performs other duties plus his vacation time (12%) and because it is very important that contract specifications be met. Determining of priorities needs to be centralized and authorized on a weekly basis and I am the sole person in the lab who holds all the information. Responsibility for Accounting - I work directly with the Office of Research on accounting problems. Set up and Maintain Responsibility for a Client Database - I have designed, in Excel, a Client database that allows us to track clients easily and quickly. This facilitates client relations in allowing us to give them better service and send them information about changes in our laboratory Responsibility for Interviewing, Hiring and Firing of Office Staff - I am responsible for interviewing, hiring and firing full-time and part-time office staff. I have made it my responsibility to determine the legalities involved in this and to ensure that my office staff is treated fairly and correctly. Responsibility for Pricing for Analyses - I set up the initial pricing requirements (overhead, labor and consumables) and determine the prices depending on the specific overhead and comparison with other laboratories which perform similar analyses to our. We have seven different pricing systems, all of which have separate overhead structures. The final pricing is determined in consultation with the lab manager. Responsibility for Approving Staff Overtime - I have been given the authority to approve all overtime and, in conjunction with this, I look for proof in terms of increased productivity. Responsibility for Public Relations - I am now sharing responsibility with the lab manager for soliciting business externally through attendance at conferences. At these conferences, I act as a representative of the University of Waterloo as well as the Environmental Isotope Laboratory. These duties allow me to use my understanding of the scientific basis for what we do at the Environmental Isotope Laboratory and of the technical procedures we follow to discuss potential uses with prospective clients. As a representative of the University of Waterloo and as a graduate thereof, I also discuss the University as a whole and the student services offered by it. Increased Responsibility for Client Relations - With the frequent business absences of the lab manager (approximately 25% of the time) and his allowed vacation time (approximately 12% of the time), the promotion of good client relations has become my responsibility. I have been given authority to schedule rush samples as necessary, to schedule repeat analyses if the client is not satisfied with his/her results and for waiving charges for analyses should that be necessary. Responsibility for Interpersonal Relations Among Staff - I am expected to discuss interpersonal problems and to effect solutions. As our lab has grown, this has become an important function as the occasional disputes arise. Responsibility for Graduate Student Safety - As students are placed in our lab to learn the analytical and scientific techniques we teach, I have been given responsibility to ensure their safety through setting up WHMIS training sessions, showing them placement of laboratory safety features and ensuring that they are given proper introduction to laboratory methods and procedures.

Responsibility for In-house Safety Procedures and Training - I reinforce the need for proper safely methods and arrange for safety training in particular aspects of laboratory work (e.g. correct use of gas cylinders) as necessary. Responsibility for External Contacts with Other Labs - We work in conjunction with other labs and my responsibility is to ensure friendly relations and understanding of their needs as well as our own. Responsibility for Giving Scientific Advice and Interpreting Results - In the past, this was the responsibility of the lab manager. As I have upgraded my scientific and technical knowledge, I have been given responsibility for some of this.

Job Description (bookkeeper) The duties and responsibilities of bookkeepers may vary from company to company. Usually, a bookkeeper working for a smaller company will have a larger range of functions to perform, some of which may not directly be within the scope of bookkeeping. In a larger company, his job will be restricted only to bookkeeping as the company will employ other people for other tasks related to accounting. Sometimes, he may be required to start from an entry-level clerical job so as to understand the job responsibilities better, which definitely adds to work experience. Overall, a bookkeeper may be expected to perform some or all of the following functions based on his education, experience, and the type of organization he works for, in accordance with the accounting laws and standards of the country of operation. Maintaining the financial records of the company using bookkeeping software and online spreadsheets Maintaining supporting documentation as ready reference of any recorded transaction Maintaining records of subsidiaries Preparing and processing payroll/s Checking financial reports and records for accuracy Preventing, rectifying, or reporting errors made while recording, posting in or balancing any account Reconciling all accounts periodically Preparing monthly, quarterly, half-yearly, and yearly financial statements Calculating taxes, collecting bad debts, paying creditors, and analyzing financial statements Designing the accounting system for the company (if it is a start-up) Assisting with preparation for audits Producing accounting reports and income and expenditure statements Drawing up the trial balance and the balance sheet of the company at the end of the year Maintaining the petty cash fund Maintaining and ordering office supplies Processing sales invoices, receipts and returns Maintaining past accounting records of the company Assisting in the development of the annual budget of the company and monitoring the budget Maintaining a monthly profit and loss statement Assessing investments made by the company periodically and overseeing cash flow Safeguarding and securing all financial records of the company

Staying up-to-date with changes in the state and country-wide financial laws Educational Qualifications and Other Requirements The preferred educational requirements of a bookkeeper are as follows. An associate's or bachelor's degree in accounting Bookkeeping certification (obtainable after 2 years of bookkeeping experience), with continuing education every 3 years to maintain the certification While basic education is mandatory, most learning is accomplished on the job, which takes about 6 months. Apart from the aforementioned education, a bookkeeper is expected to be well-versed with accounting practices, the GAAP and the tax laws of the country of operation. In addition to this, he should also be computer literate and know how to operate the various accounting software along with MS Office. In addition to the above, he may also need to be well-versed with data management and financial data analysis software, in case he is also in charge of analysis of financial statements and data. A bookkeeper is expected to be highly accurate, and possess the knack to spot any glitches in records. Presence of mind, excellent organizational skills, and the ability to learn and adapt quickly are skills that are mandatory for any candidate willing to take up this profession. Read more at Buzzle: http://www.buzzle.com/articles/bookkeeper-job-description.html

Bookkeeper Job Description

Position Description: Bookkeeper Basic Function: The bookkeeper position creates financial transactions and creates financial reports from that information. The creation of financial transactions includes posting information to accounting journals or accounting software from such source documents as invoices to customers, cash receipts, and supplier invoices. The bookkeeper also reconciles accounts to ensure their accuracy. Principal Accountabilities: 1. Purchase supplies and equipment as authorized by management 2. Monitor office supply levels and reorder as necessary 3. Tag and monitor fixed assets 4. Pay supplier invoices in a timely manner 5. Take all reasonable discounts on supplier invoices 6. Pay any debt as it comes due for payment 7. Monitor debt levels and compliance with debt covenants 8. Issue invoices to customers

9. Collect sales taxes from customers and remit them to the government 10. Ensure that receivables are collected promptly 11. Record cash receipts and make bank deposits 12. Conduct a monthly reconciliation of every bank account 13. Conduct periodic reconciliations of all accounts to ensure their accuracy 14. Maintain the petty cash fund 15. Issue financial statements 16. Provide information to the external accountant who creates the companys financial statements 17. Assemble information for external auditors for the annual audit 18. Calculate and issue financial analysis of the financial statements 19. Maintain an orderly accounting filing system 20. Maintain the chart of accounts 21. Maintain the annual budget 22. Calculate variances from the budget and report significant issues to management 23. Comply with local, state, and federal government reporting requirements 24. Process payroll in a timely manner 25. Provide clerical and administrative support to management as requested