Overview
Senior Quality Assurance Specialist Jobs in San Jose, CA at Kelly Science, Engineering, Technology & Telecom
Title: Senior Quality Assurance Specialist
Company: Kelly Science, Engineering, Technology & Telecom
Location: San Jose, CA
Kelly® Science & Clinical is seeking a Senior Quality Assurance (QA) Specialist for a 6-month contract position at a premier biotech company in San Jose, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Pay Rate:
$50-55/hour
Overview:
In this role, you will ensure quality and compliance by managing documentation, supporting manufacturing operations, overseeing product release activities, handling investigations and quality records, and assisting with audits as a key member of the QA team.
Schedule:
Monday-Friday, 8:00am to 5:00pm, occasional weekend/evening shifts on a rotation basis (every 4-5 weeks)
Responsibilities:
- Author, review, and revise documentation such as SOPs, policies, and standards to ensure strict adherence to GMP (Good Manufacturing Practice) requirements.
- Provide direct, on-floor QA support for manufacturing operations.
- Perform and oversee lot disposition and product release activities for clinical and commercial products, ensuring compliance with regulatory and quality standards.
- Conduct thorough reviews of batch production records, quality control testing data, and equipment maintenance/calibration documentation, and lead investigations related to product quality.
- Collaborate with the QA team to maintain accurate quality records and assist in hosting client and regulatory audits, supporting a culture of continuous improvement and compliance.
- Other duties as assigned.
Qualifications:
- Bachelor’s degree in Science or related field.
- 5+ years of QA experience in a biotech or pharma GMP environment.
- Experience with lot release and disposition.
