- Performs testing and associated tasks without errors per applicable SOPs and protocols.
- Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
- Develops and maintains SOPs
- Develops expertise in assigned assays/techniques * Authors deviation and invalid assay assessments * May be required to perform shift work as required to support the operations
Minimum Required Qualifications for Level II:
- 3+ years of laboratory experience OR equivalent * Intermediate knowledge of GMPs, safety regulations and data integrity * Intermediate knowledge of analytical methods and related instrumentation * Experience performing PCR
Minimum Required Qualifications for Level I:
- 6 months or more laboratory experience OR equivalent * Basic knowledge of GMPs, safety regulations and data integrity * Basic knowledge of analytical methods and related instrumentation * Some knowledge of performing PCR
Required for BOTH Level I and Level II:
- BS/BA in Biochemistry, Virology, or other related science field * Experience with maintaining cell lines, cell passaging, or cell counting techniques * Some experience with working in an analytical testing lab (academic or industry) * Current flu vaccine
Preferred / Nice to Have Qualifications for either Level:
- Experience working in a cGMP Pharmaceutical Laboratory * Experience with Laboratory Information Management Systems (LIMS) * Experience performing Virus Titer assays, Residual Infectious Virus assays and other virology-based testing methods