Biotech QA Specialist - Raw Materials & QC

Astrix; New Jersey; On-site; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in New Jersey is seeking a QA Specialist to ensure the quality and compliance of raw materials in biotechnology manufacturing. This role requires a Bachelor’s degree in a scientific discipline and 2–5 years of QA experience in the biopharmaceutical industry. Key responsibilities include reviewing documentation, conducting audits, and supporting quality improvement initiatives. The ideal candidate will have strong knowledge of GMP regulations and analytical data review skills, along with the ability to collaborate across teams.

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.

Responsibilities

• Review and approve raw material documentation for accuracy and compliance.
• Perform raw material release activities in accordance with established SOPs and GMP requirements.
• Coordinate and review raw material sampling to ensure proper identification and chain of custody.
• Review QC laboratory documentation and analytical data for compliance with procedures.
• Review and track stability reports, ensuring timely completion and accuracy.
• Support investigations, deviations, CAPAs, and change controls.
• Collaborate with Quality Control, Supply Chain, and Manufacturing.
• Participate in internal and external audits as needed.
• Identify opportunities for continuous improvement in quality systems.

Skills

Quality Assurance

GMP regulations

Analytical data review

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

Job description

A leading pharmaceutical company in New Jersey is seeking a QA Specialist to ensure the quality and compliance of raw materials in biotechnology manufacturing. This role requires a Bachelor’s degree in a scientific discipline and 2–5 years of QA experience in the biopharmaceutical industry. Key responsibilities include reviewing documentation, conducting audits, and supporting quality improvement initiatives. The ideal candidate will have strong knowledge of GMP regulations and analytical data review skills, along with the ability to collaborate across teams.