Position Title: Quality Control Analyst I

Reports To: Quality Control Manager

Department: Quality Control
Date Revised: April 2013
FLSA Status: Non-Exempt (hourly)


Summary:

The position will include routine testing of in-process and final container samples for the release of avian
vaccines. The individual will be responsible for ensuring all methods are performed as written and filed with
regulatory agencies.


Duties and Responsibilities:
1. Perform required tests for bulk antigens, final products, and raw materials, as well as other procedures
necessary to support company and laboratory objectives under cGMP and GLP guidelines to meet specified
timelines.
2. Participate in testing as required supporting microbial identification and bio burden analysis. Will be required
to read microbial plates and interpret test results.
3. Environmental monitoring of clean rooms and personnel: assisting in and/or performing microbial and
particulate tests (air sampling, taking laser particle counts and water sampling). Updates environmental
monitoring results database and prepares monthly report.
4. Maintain aseptic laboratory technique at all times and insures accuracy of test results through precision and
attention to detail.
5. Operate and proactively maintains laboratory equipment. Ensure that equipment maintenance is properly
documented in a timely manner.
6. Maintain accurate and concurrent testing records and ensure compliance with Company SOPs and
specifications, USDA and cGMP regulations.
7. Participate at the direction of the QC Manager to support Research and Development, Production, Process
Improvement, and/or other Departments to achieve Company quality objectives.
8. Rely on instructions and Standard Operating Procedures to perform all functions of the job. Draft and revise
standard operating procedures and assist with validating and troubleshooting assays.
9. Actively contribute to a team setting with the laboratory and potentially with other work teams to increase
efficiency, solve problems and improve quality.
10. Provide backup support for virology and tissue culture assays for other QC Analysts.

Additional Duties May Include:
11. Occasional weekend and off-hour work may be required.
12. Other duties as assigned by the QC Manager.




J ob Description
Qualifications:

Bachelor degree in Biological Sciences or associates degree with two or more years of laboratory experience in
biotechnology and aseptic processing required. Working knowledge of the following assays desirable: Detection
of Extraneous Viable Bacteria and Fungi, Detection of Mycoplasma Contamination, Detection of Salmonella
Contamination, Determination of Moisture Content, Sterile Diluent Testing, Animal Origin Ingredient Testing, Live
Bacterial Vaccine Titrations, Raw Material Testing, Emulsion Analysis (Viscosity, Stability, Appearance) etc.
Understanding of Good Laboratory Practices (GLP) and good aseptic technique required. Must be able to
understand and apply cGMP requirements. Understanding of and ability to insure compliance with current and
changing USDA and EU guidelines. Working knowledge of Code of Federal Regulations, Article 9, and European
Pharmacopeia desireable. Quality Management System experience desirable (ISO 9001-2008) preferred.

Good record keeping, organizational, written and verbal communication skills are essential. Competent with a
general knowledge of Word processing and spreadsheets (such as Microsoft Office). Must be able to work in a
team environment, handle multiple tasks simultaneously and complete tasks in a timely manner. Must be
detailed oriented, conscientious and responsible.


Note: All LAHI job descriptions are guidelines to assist employees in awareness of qualifications and performance
expectations for their respective positions. It is not possible or desirable to commit every detailed aspect of each job to a
written description. Each employee is expected to continually improve their knowledge and understanding of their job
requirements and to use this information to increase insight as to the scope of their responsibilities. J ob descriptions cannot
be used as an argument to refuse work assignments.




Incumbent Signature Date