QMS Associate, Sterile Injectables

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,/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

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.

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.

• 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

• 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 (Track Wise 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

• 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

• 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…