Senior Quality Assurance Specialist

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.