Description
Candidates must be local to the San Diego/ Carlsbad areas. We currently have multiple quality openings consisting of Sr. Supplier Quality Auditor, Quality Associate II, Validation, Sr. Quality Assurance Associate, QA Document Control Specialist, and Document Specialist. If you have Quality Assurance, Validation, or Document Control experience in a Pharmaceutical/ Biotech environment, please apply and one of our dedicated recruiters will reach out to you!Sr. Quality Assurance Associate
Position and Scope
The purpose of this position is to perform tasks pertaining to assurance compliance with quality requirements, including review of drug product and medial fill production batch records and associated documentation required to release a production lot.
Other duties include performing investigations, conducting internal audits, and visual inspection of finished product.
Specific Responsibilities
The successful candidate will:
· Review production of media fill and 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 as needed including preparation of audit report and follow-up
· Host and/or assist with client audits when required
· Lead and/or assist investigations into quality issues such as non-conformances, complaints and Corrective and Preventive Actions (CAPAs)
· Perform visual inspection of finished product
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 cGMP regulations 21CFR Part 11, 210, 211, & EU guidelines and good documentation practices
· High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
Education/Qualifications
· Minimum three (3) years of relevant experience in documentation review, QA or equivalent
· Minimum one (1) year of fill finish production batch review experience
· Bachelor's degree strongly preferred in a Life Sciences discipline or equivalent
· Must be able to effectively communicate within the department and cross-functionally throughout the organization
