Quality Assurance, Batch Reviewer – DPM
Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.
Position and Scope
The purpose of this position is to perform tasks pertaining to assurance compliance with quality requirements, including review of production batch records and associated documentation required to release a production lot.
Other duties include performing investigations, conducting internal and supplier audits, hosting client audits, and visual inspection of finished product.
The successful candidate will:
- Review production of drug product batch record and associated documentation for release
- Investigate discrepancies and ensure all issues are resolved
- Prepare Certificate of Compliance (COC) or Certificate of Analysis (COA), as required
- Perform line clearance functions for cGMP processes
- Support manufacturing operations and staff to address product quality and compliance issues, as they arise
- Conduct internal audits and supplier qualification audits, as needed, including preparation of audit report and follow-up
- Host client audits when required
- Lead and/or assist investigations into quality issues such as complaints and Corrective and Preventive Actions (CAPAs)
- Perform visual inspection of finished product
- Perform logbook documentation audits for cGMP regulated logs and SOPs
Position Requirements and Experience
The desired candidate will have:
- Superior attention to detail, organizational skills, and the ability to multi-task in a time-line driven environment
- Experience working in the pharmaceutical manufacturing industry
- Proven problem-solving skills
- Excellent oral and written communication skills, and listening skills
- Working knowledge of GLP and cGMP regulations 21CFR Part 11, 210, 211, EU guidelines, and good documentation practices
- High school diploma is required. Bachelor’s degree is strongly preferred in a Life Sciences discipline or equivalent
- Minimum three (3) years of relevant experience in documentation review, QA or equivalent
- Minimum one (1) year of batch review experience
- Knowledge of Fill Finish production environments strongly preferred
- Must be able to effectively communicate within the department and cross-functionally with other divisions
- High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.
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