Quality Control Technician/Microbiologist

Summary: Perform a variety of tests, evaluations and analyses to determine the compliance of incoming, in process and finished product with specifications and standards.  Record and report results as required and take appropriate action.

Shift: First – 8:00am – 4:30pm some overtime may be required.

Responsibilities:

1. Accurately conduct a variety of tests – microbiological, chemical, physical, and occasional analytical – on samples representative of incoming raw materials, batches and intermediate and finished product to determine their compliance with requirements with primary focus on microbiological testing.  Record results and maintain documentation as required following cGMP requirements.  Take appropriate action when non-compliance is determined.
2. Prepare microbiological media according to USP requirements including growth promotion.
3. Prepare inoculant, perform streaks, subculture, and make gram stain determinations as needed.
4. Sterilize prepared media and other items as required using an autoclave.
5. Conduct a variety of stability tests to support accelerated temperature and long term room temperature stability programs.  Assure accurate performance of tests and data reporting.
6. Appropriately react to evidence of a quality problem.  Communicate observations of non-compliance to cGMPs or procedure to the QC Supervisor.
7. Assure proper maintenance, operation checks and calibrations are performed as needed.  Assure records are accurately completed, calculations are checked and calibration stickers are updated.
8. Participate in validations and qualifications as required.
9. Participate in training/cross-training and provide training as required for other QC/QA and Production personnel.  Participate in customer and regulatory audits as needed.  Assure compliance with procedures such as handling out of specification data.
10. Assist with raw material sampling and testing program.
11. Perform other duties as required

Reporting Relationship: This position reports to the QC Supervisor.

Qualifications: Requires four year Bachelor Degree or two year associates degree in science or math with at least two years of college level chemistry and biology with related experience.  One to Two years work experience in quality control or assurance in a regulated industry such as food, cosmetics or drug manufacturing with microbiological testing according to USP <60, 61, 62> preferred.  Knowledge of statistics and basic FDA GMP requirements.  Basic knowledge and skills sufficient to manipulate and use Microsoft and other software including word processing, spreadsheets, email, internet and MRP systems.