Quality System Specialist, Sterile Drug Products

Kelly® Science & Clinical is seeking a Quality Management Systems Specialist 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.

• 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

Step into a vital leadership role in Sacramento’s vibrant life sciences sector. We’re seeking a proactive Quality Assurance QMS Specialist with expertise in parenteral drug products to champion our continuous improvement and compliance initiatives. Drive CAPA excellence, mentor operational teams, and play a critical part in safeguarding product quality, patient safety, and regulatory readiness.

As a QMS Specialist, you’ll be at the forefront of our parenteral manufacturing quality system—collecting and analyzing information to identify, mitigate, and prevent quality and product issues. You’ll collaborate closely with the Site Quality Lead Team and mentor site personnel, ensuring effective root cause analysis and robust corrective and preventive actions. By cultivating best practices in deviation, change control, and CAPA, your work will directly enable superior product performance, process improvements, and regulatory success.

• Lead and coach operations and cross-functional teams in Change Control, Deviation Management, and CAPA programs—building a strong culture of quality and ownership.
• Drive rigorous investigations, root cause analyses, and implementation of corrective and preventive actions to eliminate recurring issues in sterile product manufacturing.
• Design, manage, and sustain a site-wide CAPA program, collaborating with function owners to proactively capture both existing and potential quality risks.
• Compile and present CAPA program metrics to the Site Quality Lead Team, delivering actionable insights and improvement plans.
• Ensure timely and thorough completion of deviations and CAPAs, with close monitoring and rapid escalation of overdue or complex events.
• Act as lead instructor, educating site teams on Change Control, Deviation Management, and CAPA best practices.
• Coach lead investigators on technical writing to increase rigor, accuracy, and compliance in documented investigations.
• Serve as a Subject Matter Expert and primary author for site CAPA and Deviation Management procedures and periodic reviews.
• Initiate and support site-wide quality investigations, trends analysis, and technical improvement projects.
• Foster a deep understanding among site personnel of how the CAPA program drives product/process improvement and compliance.
• Benchmark and implement best-in-class practices in collaboration with the network deviation program mentor.
• Lead and optimize the implementation of the electronic Quality Management System (eQMS) across departments.

• Bachelor’s or Master’s degree (Life Sciences or Engineering preferred), or equivalent experience in a GMP-regulated environment
• 3+ years of experience in GMP pharmaceutical or parenteral manufacturing (Quality Assurance or Engineering roles preferred)
• In-depth knowledge of cGMP, FDA regulations (21 CFR), and sterile manufacturing quality systems
• Strong proficiency with electronic QMS platforms and CAPA systems
• Demonstrated expertise in root cause investigation, deviation management, and change control
• Exceptional communication and interpersonal skills—able to explain, influence, and lead across all levels of the organization
• Ability to thrive under pressure, make sound judgments, and lead independently with minimal supervision
• Skilled at managing multiple priorities and tasks in a dynamic environment

• Experience authoring technical CAPA/deviation documentation and leading process audits or…