Job Purpose: The main purpose of this job is to perform data review and approve routine analytical testing on raw materials, incoming materials, finished goods, stability and other samples as needed. Support site audit inspection preparation and participate as an audit team member in audits. It is also important to participate in OOS, investigations, and cross functional improvement teams to provide analytical expertise.
- Ensure quality and compliance in accordance with established procedures and standards of the Quality System.
- Comply with and support the GSK Environmental, Health and Safety policies and procedures.
- Perform data review for completeness and compliance with cGMPs as per regulatory requirements and internal procedures for raw materials, incoming materials, finished products, stability samples, and all other related samples.
- Approve materials for further processing following applicable procedures.
- Participate, lead and support audits (internal and external), and work to resolve any resulting findings.
- Write, review, and update Analytical SOPs, methods, and Quality Control Specifications.
- May participate in review and approval for investigations associated with Deviations, CAPA, OOS, Out of Tolerance, Atypical Results, Environmental Discrepancy Reports and Alert Level Reports.
- Other duties as assigned
- Bachelor's of Science/Arts in Chemistry, Biology, Analytical or some related life science (with hands-on related lab classes)
- At least 5-year experience of routinely processing a variety analytical samples in a quality control laboratory with minimal supervision in a Pharmaceutical setting.
- Bachelor of Science in Chemistry
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