QMS Specialist, Sterile Injectables

Kellyu00ae 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 Sacramentou2019s vibrant life sciences sector. Weu2019re 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, youu2019ll be at the forefront of our parenteral manufacturing quality systemu2014collecting and analyzing information to identify, mitigate, and prevent quality and product issues. Youu2019ll 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 Youu2019ll Do: + Lead and coach operations and cross-functional teams in Change Control, Deviation Management, and CAPA programsu2014building 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: + Bacheloru2019s or Masteru2019s 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 skillsu2014able 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 Sacramentou2019s 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 u00ae 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 worldu2019s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsu2014itu2019s 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, weu2019re obsessed with where it can take you. To us, itu2019s about more than simply accepting your next job opportunity. Itu2019s the fuel that powers every next step of your life. Itu2019s 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 lifeu2014just 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 Californiau2019s 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.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellyu2019s Human Resource Knowledge Center. Kelly complies with the requirements of Californiau2019s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Created: 2026-04-04