Kelly® Science & Clinical is seeking a Quality Management Systems Associate for a direct hire opportunity with a leading specialty pharmaceutical company in Sacramento, 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: Onsite in Sacramento, CA.
Position Title: Quality Management Systems Associate
Position Type: Direct hire
Salary Range: 70,000-80,000/year
Benefits:

• Yearly bonus eligibility
  

• Our client offers a wide variety of benefits and programs to support health and well-being
  

• Medical, dental, and vision coverage
  

• Paid time off plan
  

• 401k savings plan

Overview
Are you eager to launch your career at the heart of Sacramento’s thriving life sciences and pharmaceutical innovation corridor? Join our dynamic team as a QMS Associate and play a pivotal role in safeguarding product quality and patient safety, while developing in-demand regulatory expertise valued in the Sacramento and global markets.
What You’ll Do
As a QMS Associate, you’ll be the driving force behind our commitment to excellence, bridging cross-functional teams across Manufacturing, Engineering, Quality Control, and Validation. You will coordinate and support every stage of deviation management within our leading-edge electronic Quality Management System (eQMS), ensuring full compliance with cGMP, FDA, and internal standards.
Key Responsibilities:

• Manage the intake, triage, and tracking of deviations using state-of-the-art eQMS tools
  

• Perform initial risk/impact assessments to determine criticality and investigation needs
  

• Lead and coordinate cross-functional root cause investigations, ensuring thorough documentation and rapid resolution
  

• Develop, implement, and track Corrective and Preventive Actions (CAPAs), verifying effectiveness to drive continual improvement
  

• Ensure investigations and CAPAs are closed within target timelines, escalating issues proactively to leadership
  

• Review reports for regulatory and technical accuracy, supporting robust data integrity
  

• Analyze and identify deviation trends, supporting the generation of actionable quality metrics
  

• Contribute to periodic Quality Risk Assessments (FMEA, etc.) and support product impact evaluations
  

• Partner with QA leadership during regulatory inspections and internal audits, providing critical documentation and insights
  

• Ensure ongoing compliance with 21 CFR Parts 210/211 and company quality procedures
  

• Participate in ongoing process improvement initiatives to enhance deviation resolution and prevent recurrence

What You Bring:

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy or related field; or equivalent GMP experience in a regulated manufacturing environment
  

• 0–3 years of GMP, pharmaceutical, biotech, or regulated industry experience (Sacramento or CA regional experience a plus)
  

• Working knowledge of cGMP and FDA (21 CFR) regulations
  

• Familiarity with deviation management, CAPA processes, and root cause analysis tools (TrackWise eQMS experience highly valued)
  

• Strong understanding of sterile manufacturing, aseptic techniques, environmental monitoring, and contamination control
  

• Excellent analytical, technical writing, communication, and organizational skills
  

• Proficiency with Microsoft Office and comfort learning new digital quality platforms
  

• Experience with quality metrics trending and risk management principles (ICH Q9) preferred
  

• Exposure to investigation tools (5-Why, Fishbone, Fault Tree Analysis) is an asset

Why Join Us in Sacramento?

• Be part of Sacramento’s rising biotech region, offering strong career progression, community, and access to top research institutions
  

• Collaborative, mission-driven culture that values your insight and innovation
  

• Opportunity to grow your regulatory expertise and advance in quality roles

Physical / Work Environment:

• Primarily office-based, with periodic access to manufacturing and controlled environments (gowning required as needed)
  

• Standard day schedule with flexibility to support critical quality events
  

• Ready to play a key role in Sacramento’s leading-edge life sciences sector? Apply now and accelerate your career in Quality!

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