Senior Quality Assurance Specialist

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.
  
  

 

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

10239804