Quality Control Analyst
Raleigh Metro Area, North Carolina
- Execute method validation and transfers for assigned virology.
- Ensure that samples are tested according to quality requirements defined via registered specifications in accordance with local/international regulations. Maintain cell lines used for testing.
- Ensure results reported are valid, accurate and documented per applicable regulatory and corporate requirements.
1. Perform general mammalian cell culture and cell culture support activities
2. Perform cell culture based safety testing in support of primary and secondary operations- Virus Infectivity, Residual Infectious Virus, Adventitious Virus, Identity assays, etc.
3. Perform cell culture based validation testing in support of primary and secondary operations- Virus Infectivity, Residual Infectious Virus, Adventitious Virus, Identity assays, etc.
4. Perform routine and preventative maintenance on laboratory equipment and general laboratory duties in support of PCR and Virology laboratories Support group compliance activities, including investigations, SOP revisions
5. Maintain compliance with cGMP requirements within the laboratory
BS degree in science with 1 to 3 years directly related laboratory experience or equivalent education experience combination.
Knowledge of virology assays. Strong knowledge of cell line maintenance.
Knowledge of GMPs, safety regulations and data integrity
Education: BS degree in Biochemistry, Biology, immunology or other related scientific field