MCS Associate Quality Assurance

100% Thousand Oaks Schedule will be 7am -4pm, Flexibility to potentially work swing shift 18 months possible extension. Ideal Candidate: Looking for candidate committed to working the duration of the contract. 5 years of QA experience in the biotech industry, with a focus on GMP compliance Hands-on experience in manufacturing, packaging, and labeling sampling for Biotech/pharma Proficiency in SAP and MES for batch record review and sampling documentation Strong attention to detail and excellent communication skills Values continuous improvement and proactively identifies areas for operational efficiency Job Details: This position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality data and reports (e.g. lot track/trace, deviations). Individual will also assist with procedure reviews and initiation of deviation reports. There is the potential for role expansion into support of a product distribution function. Skills: ; quality assurance or manufacturing experience in the pharmaceutical industry Must have experience with GMP processes and documentation. Without that fundamental skillset the training for document review tasks, label approval and packaging inspection will have no foundation. Must be able to methodically and meticulously inspect printed materials for print quality defects, clinical product components (e.g. syringes and vials) for physical defects, and batch record documentation for accuracy and completeness. Must be able to work in a team with shifting priorities and shifting responsibilities, such that the team members must be confident verbal communicators able to discuss responsibilities, divide them, reassess them, and potentially reassign them throughout the day or week.