QMS Specialist, Sterile Injectables Job Listing at Kelly Services in Sacramento, CA (Job ID 10142896)

Description

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.
Workplace: Onsite in Sacramento, CA.
Position Title: Quality Management Systems Specialist
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
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.
Your Impact:
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.
What You'll Do:

• 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.

What You Bring:

• 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

Preferred Skills:

• Experience authoring technical CAPA/deviation documentation and leading process audits or regulatory inspections
• Strong organizational, time-management, and analytical abilities
• Demonstrated ability to drive culture change, engage teams, and lead quality initiatives

Additional Information:

• Flexibility to work variable hours and provide shift or weekend coverage as business demands
• On-call availability required for urgent quality events

Why Sacramento? Why Us?

• Play a meaningful role in the growing Sacramento life sciences cluster, supported by stellar research institutions and a collaborative local biotech community
• Build your expertise and make a tangible difference in the quality and safety of high-impact injectable medications
• Thrive in a culture committed to professional growth, operational excellence, and patient-focused outcomes

Ready to elevate your quality career and drive innovation at the forefront of Sacramento's pharmaceutical industry? Apply today and lead the way in parenteral QMS excellence!
 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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