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ApTask

MCS Associate Quality Assurance

ApTask, Westlake Village, California, United States, 91361


About Client: The client is one of the world's largest independent biotechnology companies, focusing on the discovery, development, and manufacturing of innovative human therapeutics. The company's areas of expertise include oncology, hematology, cardiovascular disease, inflammation, bone health, and neuroscience. It has developed a wide range of biologic medicines, including biotechnology drugs, therapeutic antibodies, and other innovative therapies. The company collaborates with academic institutions, biotechnology partners, and other organizations to advance its research efforts. Rate Range: $25-$30.35/Hr Job Description: 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 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. Non-benefitted (other than those mandated under state or federal law).Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees. About ApTask: ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment. Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview. Candidate Data Collection Disclaimer: At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment. If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellenceaptask.com