QA Specialist II/III (Production)

Responsibilities

• Provide day-to-day Quality Assurance support for GMP manufacturing operations.
• Spend approximately 80% of the workday on the production floor supporting manufacturing personnel.
• Review batch production records (BPRs) in real time to ensure accuracy and GMP compliance.
• Approve line clearances and support manufacturing activities during production.
• Review and approve GMP documentation including batch records, validation protocols, reports, specifications, and supporting documentation.
• Support electronic batch release systems and perform usage decisions.
• Investigate and support deviations, CAPAs, OOS investigations, and other quality events.
• Review QC data, including chromatograms and laboratory documentation.
• Participate in document control, change controls, validation, qualification, and calibration activities.
• Analyze and trend quality data to identify opportunities for continuous improvement.
• Recommend and implement improvements to quality systems and SOPs utilizing Lean GMP principles.
• Collaborate with Manufacturing, QC, and cross-functional teams to resolve quality issues and close quality records.
• Provide GMP guidance and training to manufacturing and support departments.
• Participate in internal, customer, and regulatory audits and support FDA inspections.
• Aid in writing and revising SOPs, specifications, protocols, and other quality documents.
• Promote a strong quality culture throughout the organization.

Qualifications

• Education: Bachelor's degree in Chemistry, Organic Chemistry, Biology, or another related scientific discipline required. Master's degree preferred. Associate's degree will be considered with additional relevant experience. High school diploma alone will not be considered.
• Experience:
  • QA Specialist II: 3–5 years of Quality Assurance and/or Quality Control experience within pharmaceutical, biotech, or biologics manufacturing. Associate's degree candidates should possess at least 5 years of relevant experience.
  • QA Specialist III: 4–6 years of Quality Assurance and/or Quality Control experience within pharmaceutical, biotech, or biologics manufacturing. Associate's degree candidates should possess at least 7 years of relevant experience.
• Required Qualifications:
  • Experience supporting GMP manufacturing or production floor operations.
  • Experience performing batch record review.
  • Experience reviewing QC data and chromatograms.
  • Experience with deviations, CAPAs, and OOS investigations.
  • Experience with GMP document control.
  • Knowledge of validation, qualification, and calibration activities.
  • Experience working in ISO 7 and/or ISO 8 controlled manufacturing environments.
  • Strong understanding of FDA and GMP regulations.
  • Excellent attention to detail and ability to work in a fast-paced manufacturing environment.
  • Strong communication and collaboration skills.
  • Proficiency with Microsoft Word, Excel, and PowerPoint.
• Preferred Qualifications:
  • Experience with peptides, oligonucleotides (oligos), APIs, biologics, or pharmaceutical products.
  • Experience with GxP regulations.
  • Experience participating in FDA, customer, or internal audits.
  • Experience with Quality Management Systems such as MasterControl or Veeva.
  • ASQ certifications such as: Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Certified Quality Process Analyst (CQPA).

Interview Process

• Two interview rounds:
• Virtual interview with the Hiring Manager
• Onsite interview with the QA team