QA Specialist

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

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.

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!

Seniority level

Associate

Employment type

Contract

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing and Biotechnology Research