QA Specialist II; Biotech​/Pharma)

Location: Vista, CA

Job Type: Contract through June 2027

Pay Rate: $45/hour

Schedule: Monday–Friday, 8:00 AM–5:00 PM

Start Date: ASAP

Work Arrangement: Onsite

We are seeking an experienced Quality Assurance Specialist to support GMP quality operations at a pharmaceutical/biotechnology manufacturing facility in Vista, CA.

This position will be responsible for managing quality investigations, deviations, Corrective and Preventive Actions (CAPAs), Out-of-Specification (OOS) investigations, and regulatory compliance activities to ensure pharmaceutical drug substances meet FDA and international quality standards.

The ideal candidate will have 5+ years of Quality Assurance experience within GMP-regulated pharmaceutical or biotechnology manufacturing
, with a strong background in quality investigations, root cause analysis, CAPA management, and internal audits.

This individual will work closely with manufacturing, quality control, and cross-functional teams to resolve complex quality issues, identify potential risks, and drive continuous improvement initiatives.

• Serve as the designated QA reviewer and approver for critical quality events, including deviations, CAPAs, OOS investigations, and nonconforming materials.
• Lead complex quality investigations, performing root cause analysis (RCA) to identify underlying issues and implement corrective actions.
• Manage and facilitate cross-functional investigation teams involving Manufacturing, Quality Control, Engineering, and other departments.
• Review, author, and approve detailed investigation reports, ensuring documentation is accurate, complete, and audit-ready.
• Develop, implement, and monitor CAPA plans to address quality issues, mitigate risks, and prevent recurrence.
• Evaluate CAPA effectiveness and recommend improvements to strengthen quality systems and manufacturing processes.
• Support internal audits, customer audits, and regulatory inspections to ensure compliance with applicable GMP requirements.
• Identify potential compliance risks and recommend corrective actions to maintain quality and regulatory standards.
• Provide QA oversight and support to manufacturing operations, ensuring adherence to approved procedures and quality requirements.
• Track quality metrics, investigation timelines, and CAPA performance, providing regular updates to management.
• Collaborate with cross-functional teams to support continuous improvement and strengthen site quality systems.
• Maintain accurate documentation within electronic Quality Management Systems (QMS).

• Minimum 5 years of Quality Assurance experience in GMP-regulated pharmaceutical or biotechnology manufacturing.
• Strong hands-on experience managing deviations, CAPAs, and OOS investigations.
• Demonstrated experience conducting root cause analysis (RCA) and leading quality investigations.
• Experience supporting manufacturing operations in a GMP environment.
• Experience participating in or supporting internal quality audits.
• Strong understanding of FDA regulations, cGMP requirements, and pharmaceutical quality systems.
• Ability to independently investigate quality issues, identify risks, and implement corrective actions.
• Experience authoring, reviewing, and approving quality investigation reports and technical documentation.
• Strong organizational, analytical, problem-solving, and communication skills.
• Ability to collaborate effectively with Manufacturing, QC, Engineering, and other cross-functional departments.

• Previous experience in a QA Specialist III, Senior QA Specialist, QA Investigator, or similar role.
• Experience with in Active Pharmaceutical Ingredient (API), peptide,…