Quality Control Analyst

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, procedures and 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.