QA Specialist II​/III; Administrative

Location: Vista, CA
Schedule: Monday–Friday | 8:00 AM – 5:00 PM
Position Type: 1-Year Contract with Potential for Conversion
Pay Rate:

• QA Specialist II: $39–$52/hr (Target: ~$45/hr)
• QA Specialist III: $44–58/hr (Target: ~$50/hr)

Our client, a global pharmaceutical API manufacturer, is seeking a Quality Assurance Specialist II or III to join their growing Quality team in Vista, CA. This position is primarily an administrative Quality Assurance role, supporting GMP documentation, batch record review, document control, and quality systems while partnering closely with manufacturing to ensure compliance with FDA and international regulatory requirements.

This is an excellent opportunity for a QA professional looking to work with an industry leader in pharmaceutical manufacturing while supporting clinical and commercial products in a highly regulated GMP environment.

Approximately 70% of this role focuses on QA documentation and administrative quality activities, including:

• Review and approve batch production records (BPRs) and manufacturing documentation
• Perform real-time batch record review with accuracy and attention to detail
• Review GMP documentation including validation protocols, reports, specifications, and quality records
• Organize, maintain, and control GMP documentation within the Quality Management System (QMS)
• Support document control activities including SOPs, change controls, and controlled documents
• Review, analyze, and trend quality data to identify opportunities for continuous improvement
• Assist with electronic batch release documentation

Approximately 30% of the role involves production quality support, including:

• Support manufacturing operations on QA-related activities
• Investigate and document deviations, CAPAs, OOS investigations, and quality events
• Participate in internal GMP audits and support customer and regulatory inspections
• Collaborate cross-functionally with Manufacturing, Quality Control, Validation, and other departments
• Provide GMP guidance and support to manufacturing teams
• Assist with continuous improvement initiatives and quality system enhancements

• Bachelor's degree in Chemistry, Biology, or another scientific discipline
  • Associate degree considered with additional applicable experience
• 3-5 years of Quality Assurance and/or Quality Control experience in a GMP pharmaceutical or biotechnology environment
• Experience reviewing batch production records
• Experience with deviations, CAPAs, OOS investigations, and document control
• Experience supporting validation, qualification, and calibration documentation
• Experience working in ISO 7 or ISO 8 cleanroom environments
• Strong understanding of GMP regulations

• Bachelor's degree in Chemistry, Biology, or related scientific discipline
  • Master's degree preferred
  • Associate degree considered with 7+ years of relevant experience
• 4-6 years of Quality Assurance experience within pharmaceutical or biotechnology manufacturing
• Advanced experience with GMP documentation, batch record review, quality systems, and regulatory compliance
• Experience supporting internal, customer, and regulatory audits
• Experience implementing process improvements and mentoring junior QA staff is preferred

• Experience reviewing QC chromatograms and analytical data
• Experience with biologics, peptides, oligonucleotides, APIs, or pharmaceutical products
• Familiarity with Quality Management Systems (Master Control, Veeva, or similar)
• Experience supporting FDA inspections and regulatory audits
• ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Quality Process Analyst preferred
• Proficiency with Microsoft Office (Word, Excel, PowerPoint)

• Strong attention to detail and documentation skills
• Ability to prioritize multiple projects in a fast-paced GMP environment
• Excellent written and verbal communication skills
• Ability to work independently while collaborating across multiple departments
• Positive attitude with a willingness to learn and grow

• Opportunity to join a global leader in pharmaceutical API manufacturing
• Work alongside experienced Quality professionals in a collaborative GMP environment
• Support products from clinical development through commercial manufacturing
• Long-term contract with strong potential for permanent conversion
• Growing site with expanding Quality operations and career advancement opportunities