GMP Quality Assurance Specialist - Batch Record & Lot Release Job at Mix Talent, Milford, MA

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  • Mix Talent
  • Milford, MA

Job Description

Mix has partnered with an innovative and industry-leading company to find a talented Quality Assurance Specialist! This is a contract-to-hire opportunity, giving you the chance to showcase your skills and grow into a permanent role with an exceptional team. If you're passionate about ensuring top-tier product quality and compliance. In that case, this is the perfect fit for you! This position would be ideal for professionals with experience in life sciences, biotech, pharmaceuticals, or regulated manufacturing and hands-on expertise with Good Documentation Practice , cGMP , batch records , vendor audits , and FDA/regulatory compliance.

Why You’ll Love This Role:

  • Contract-to-Hire – Get your foot in the door with a company that values long-term talent.
  • Impactful Work – Ensure final products meet and exceed quality and regulatory standards.
  • Career Growth – Work alongside experienced quality professionals in a dynamic environment.
  • Top-Tier Industry – Join a company committed to innovation, quality, and compliance.

Your Role:

As a Quality Assurance Specialist II, you’ll be a key player in ensuring product integrity, maintaining compliance, and working directly with vendors and internal teams. You'll help maintain a Quality Management System (QMS) while supporting audits, approvals, and quality control processes.

What You’ll Be Doing:

  • Reviewing batch records, protocols, and in-process documents to ensure compliance.
  • Approving or rejecting materials, packaging, and labeling based on quality standards.
  • Communicating with vendors to collect Certificates of Analysis (CoA) and Safety Data Sheets (SDS)
  • Assisting in internal and external audits, collaborating with the Quality Assurance team.
  • Maintaining training records, quality documentation, and vendor files.
  • Supporting the qualification and approval of new vendors.
  • Helping to generate key documentation, including BSE/TSE statements and final product CoAs.
  • Ensuring adherence to Good Documentation Practices (GDP) and quality procedures.

What We’re Looking For:

  • Bachelor’s degree in a scientific discipline (or equivalent experience).
  • 2+ years of relevant quality assurance experience, preferably in manufacturing or regulated industries.
  • Strong knowledge of quality systems, regulatory compliance, and documentation best practices
  • Experience working with eQMS (electronic Quality Management Systems) is a plus.
  • Ability to effectively communicate and collaborate with vendors and internal teams.

Perks & Benefits:

  • Contract-to-Hire Opportunity – Potential for full-time employment based on performance.
  • Comprehensive Benefits
  • Career Growth Opportunities in a growing and innovative company.
  • Collaborative & Supportive Work Culture.

Compensation: $23-$35/hour - benefits offered

If you're ready to take the next step in your Quality Assurance career with a contract-to-hire role that offers long-term potential, we want to hear from you! ?

Job Tags

Permanent employment, Full time, Contract work,

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