Sr. QA Associate I Job at PCI Pharma Services (San Diego)

Job Description

The Sr. QA Associate I is a Quality Subject Matter Expert whom ensures manufacturing areas are maintained in strict compliance. Independently reviews and approves lot file documentation. Identifies and assesses regulatory and quality risks in manufacturing activities and processes. Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis. Drives process improvements and enhancements. Leads projects and trains junior staff. Provides quality expertise and guidance to operational staff.

Job Responsibility

Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas
Independently reviews and approves production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices
Independently performs quality operations within multiple manufacturing departments
Participates in multiple process improvement projects
Develop, revise, review and approve controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and tech transfer forms
Reviews and approves executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product. Represents QA for high profile clients
Provides quality oversight of quality reports including deviations, corrective and preventive actions (CAPAs) and risk management plan (RMP)
Provides quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions
Supports the Facility/Equipment/Process Change Control System including developing recommendations for change tasks, managing timelines, and performing follow-ups to evaluate the effectiveness of changes
Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Embodies PCI Pharma Services’ cultural values and aligns daily actions with department goals and company culture

Requirements

High school diploma or equivalent required
Bachelor’s degree preferred in a Life Sciences discipline or equivalent relevant experience required
Minimum of four to six (4-6) years of experience in documentation, QA, Manufacturing, technical quality, validation, or equivalent
Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity
Knowledge of Fill Finish and Biologics production environments preferred
Familiarity working with electronic batch records
Detail oriented and strong interpersonal and verbal communication skills

What we offer

eligibility for an annual performance bonus
paid time off
health insurance coverage (including dental and vision)
a flexible spending account
a 401(k) plan

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