Quality Control Analyst - Microbiology

Job Description
Job Description
Understand Regulations and business processes required to maintain Laboratory Data Integrity.
Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements
Responsible for the timely completion of testing.
Perform environmental monitoring, bioburden, endotoxin and general microbiology tests
Ensure that all test equipment is used and maintained correctly.
Ensure all in-process sampling and testing is completed on time.
Maintain up-to-date, complete and precise records of all tests performed.
Able to support manufacturing for testing during different shifts
Assist in the resolution of quality problems as required.
Develop/update in-house laboratory procedures as appropriate.
Support the transfer of new products.
Adhere to and supports all EHS &
E standards, proceduresand policies
Support the qualification of new laboratory equipment
Owning and supporting cGMP routine testing by owning quality system records required for deviations, laboratory investigations, CAPAs and out – of -specification (OOS) results
Participate in analytical method transfers and validations
Authoring and review of documents such as protocols, reports, test methods, SOPs.
Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.E. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements.