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MCS Associate Quality Assurance
Job Description
Target PR Range: 19-29/hr
*Depending on experience
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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