Pay Rate Low: 30.00 | Pay Rate High: 40.00
Pay Rate Low: 30.00 | Pay Rate High: 40.00

Raw Materials Compliance Specialist

We are seeking a Raw Materials QA Specialist for our client who has a global footprint in both R&D and manufacturing within the biopharma industry. 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.

Type: Contract-to-hire

Shift: M-F, 1st Shift

Location: Middlesex County, NJ

Pay: $30 - $40/hr

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 aseptic raw material sampling.
• 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