- 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
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