QA Specialist II

Pay rate: $35/hr – $52/hr DOE. Job type: Contract-to-hire. Location: San Diego County, CA.

About the role

The QA Specialist II is responsible for supporting day-to-day Quality Assurance operations within a GMP-regulated pharmaceutical manufacturing environment. This role ensures that drug substances manufactured meet FDA, EU, and other applicable regulatory requirements for research, pre-clinical, clinical, and commercial use. The position focuses on GMP documentation control, quality system oversight, and support of internal and external audits.

Responsibilities

• Perform production room, dispensary, and shipment clearance verifications as required.
• Review, revise, and maintain Standard Operating Procedures (SOPs) and other GMP-controlled documents such as stability protocols, raw material specifications, and environmental monitoring trend reports.
• Manage GMP documentation workflows, including reconciliation, issuance, review, and archival of records.
• Verify accuracy of scanned batch production records (BPRs), chromatograms, and other GMP documents, ensuring proper labeling, boxing, and archiving.
• Coordinate, review, and approve quality events and associated documentation.
• Support internal, customer, and regulatory audits by providing required documentation and QA guidance.
• Provide cGMP guidance to manufacturing and cross-functional departments.
• Participate in continuous improvement initiatives and represent QA in cross-functional project teams.
• Implement and maintain Quality Management System (QMS) processes and standards.
• Scan, verify, and archive GMP records in compliance with internal procedures.
• Support system and process harmonization initiatives across sites and electronic quality systems (e.g., MasterControl).

Qualifications

• Bachelor’s degree in a science-related field required; Master’s or Ph.D. preferred.
• 3–5 years of experience in Quality Assurance, Quality Control, or GMP manufacturing environment required.
• Experience working in ISO 7 and ISO 8 controlled environments preferred.
• Knowledge of FDA regulations, cGMP, GxP, and Quality Management Systems required.
• Experience with internal audits and regulatory inspections required.
• Strong ability to review GMP documents (including BPRs and chromatograms) with high accuracy.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint) and electronic document management systems.
• Strong organizational, multitasking, and time-management skills in a fast-paced environment.
• Ability to work independently and collaboratively in cross-functional teams.
• Problem-solving ability and attention to detail essential.
• Preferred certifications: ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Quality Process Analyst (CQPA).