QA Specialist, Raw Materials

Position Summary

The QA Specialist will play a key role in ensuring the quality, safety, and compliance of raw materials and related processes in support of biotechnology manufacturing operations. This position is responsible for reviewing raw material documentation, coordinating and reviewing raw material sampling and release, verifying QC data, and supporting the review of stability reports to ensure adherence to internal procedures, regulatory guidelines, and cGMP standards.

Key Responsibilities

• Review and approve raw material documentation (e.g., Certificates of Analysis, specifications, vendor documents) for accuracy and compliance.
• Perform raw material release activities in accordance with established SOPs and GMP requirements.
• Coordinate and/or review raw material sampling to ensure proper identification, handling, and chain of custody.
• Review QC laboratory documentation and analytical data for accuracy, completeness, and compliance with applicable procedures and specifications.
• Review and track stability reports, ensuring timely completion, accuracy, and adherence to protocols.
• Support investigations, deviations, CAPAs, and change controls related to raw materials and QC data.
• Collaborate cross-functionally with Quality Control, Supply Chain, and Manufacturing to ensure smooth flow of materials and documentation.
• Participate in internal and external audits, as needed.
• Identify and support opportunities for continuous improvement in quality systems and documentation processes.
  
  

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field) required.
• 2–5 years of experience in Quality Assurance within the biotechnology, biopharmaceutical, or pharmaceutical industry.
• Strong knowledge of GMP regulations (21 CFR Part 210/211) and quality system principles.
• Experience reviewing QC data, raw material documentation, and stability reports.
• Detail-oriented with strong organizational and documentation skills.
• Excellent communication and teamwork abilities.
• Proficiency with Microsoft Office and familiarity with quality management systems (QMS) or LIMS preferred.
  
  

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH