Quality Assurance Specialist

WaveCrest Staffing Group is seeking an experienced Quality Assurance Specialist to support a leading pharmaceutical manufacturing organization in Vista, CA. This role will support day-to-day quality operations, lead complex quality investigations, and ensure compliance with FDA and international regulatory requirements in a GMP manufacturing environment.

Location: Vista, CA

Pay: $40–$45/hour, depending on experience

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

Duration: Contract through June 2027

Key Responsibilities

• Serve as the designated QA reviewer and approver for critical site quality events, including deviations, CAPAs, and OOS investigations.
• Lead complex, cross-functional investigations involving critical deviations, OOS results, and non-conforming materials.
• Conduct root cause analysis (RCA) to identify underlying issues, assess risks, and determine appropriate corrective actions.
• Facilitate cross-functional investigation teams to resolve quality issues and implement effective solutions.
• Author and technically review thorough, audit-ready investigation reports.
• Develop, track, and implement CAPA plans to address systemic quality risks and prevent recurrence.
• Evaluate CAPA effectiveness to ensure corrective actions are successful and reduce recurring quality events.
• Generate and analyze quality metrics and provide regular updates on quality events and investigation status to management.
• Support continuous improvement initiatives across manufacturing and quality operations.

Requirements

• Bachelor's degree preferred.
• Minimum of 5+ years of Quality Assurance experience in pharmaceutical or biotech manufacturing.
• Strong GMP experience in a regulated manufacturing environment.
• Experience managing deviations, CAPAs, and OOS investigations.
• Demonstrated experience with root cause analysis, risk assessment, and investigation management.
• Experience supporting internal, customer, supplier, or regulatory audits.
• Experience working within a Quality Management System (QMS), including quality events, CAPAs, and related documentation.
• Strong technical writing, problem-solving, and cross-functional communication skills.
• Ability to manage complex investigations and drive quality issues through resolution.

Preferred Qualifications

• Experience supporting API manufacturing or working with peptides, oligonucleotides, or other pharmaceutical products.
• Experience interacting with regulatory agencies, including the FDA, EMA, MHRA, or Health Canada.
• Familiarity with electronic QMS platforms such as Veeva or MasterControl.

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