Job Details

Quality Assurance Specialist, Executed Batch Records

  2026-04-03     Kelly Services     Sonoma,CA  
Description:

Kelly Science & Clinical is seeking a Quality Assurance Associate for an 8-month contract opportunity with a leading biopharmaceutical company in South San Francisco, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.

Workplace: Hybrid, onsite in South San Francisco, CA, 3 days/week

Position Title: Quality Assurance Associate

Position Type: 8-month contract

Pay rate: $40-45 per hour

Are you ready to put your quality assurance expertise into action at a cutting-edge biotechnology company? We are seeking a dedicated and detail-oriented Quality Assurance Specialist to join our team on a part-time basis. This role offers the unique opportunity to gain hands-on experience supporting core Quality and Compliance functions within the dynamic biotech sector.

Key Highlights:

  • Schedule: 3 days/week (Tuesday–Thursday), on-site, 24 hours/week
  • Contract Term: April through December

Key Responsibilities

  • Review batch records and handle product complaints.
  • Organize and track documents from CDMOs (contract manufacturers) and vendors.
  • Create and maintain standardized templates for procedures and forms.
  • Support audits by sending templates to auditors, collecting necessary documents, and tracking audit progress and outcomes.
  • Track and manage other contracts and agreements, ensuring timely review, approval, and proper filing.
  • Provide other support as needed to the Quality, CMC, and Clinical Operations teams.

Qualifications

  • 2–5+ years of experience in Quality Assurance within the pharma/biopharma industry
  • Knowledge of pharmaceutical GMP (Good Manufacturing Practice) requirements.
  • Experience with Executed Batch Record review
  • Strong organizational skills and attention to detail.
  • Ability to prioritize and multitask in a fast-paced environment.
  • Excellent written and verbal communication skills.

Preferred Qualifications

  • Experience with MasterControl, SharePoint, Box, and Visio
  • Experience supporting small molecule drug development

Additional Information

  • This is an on-site position requiring weekly in-office attendance (Tuesday–Thursday) with some flexibility.

Why Join Us?

This is a fantastic opportunity for individuals passionate about quality and compliance in the life sciences field. You'll work with cross-functional teams, support critical QA operations, and contribute directly to delivering high-impact products to patients.

Apply now and help shape the future of biotechnology quality assurance!


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