- 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
- 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 regulatory inspections
- Strong organizational, time-management, and analytical abilities
- Demonstrated ability to drive culture change, engage teams, and lead quality initiatives
- Flexibility to work variable hours and provide shift or weekend coverage as business demands
- On-call availability required for urgent quality events
- 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
-
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 advancem ...
Sacramento2 days ago
-
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 advancem ...
Sacramento1 day ago
-
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 advancem ...
Sacramento, CA2 days ago
-
The Director, · Regulatory Affairs - Pharmaceuticals provides leadership, · people management, and technical expertise for · the regulatory affairs team supporting the business unit's drug product. Responsible for drug development including global regulatory strategy,<br=submissi ...
Sacramento1 month ago
-
Under indirect supervision, provides ambulatory pharmaceutical care services using approved protocols in collaboration with other health professional. · Provides direction to Pharmacist Residents, Pharmacist Interns, Pharmacy Technicians and other non-licensed personnel. · .Condu ...
Sacramento3 weeks ago
-
Clinical Pharmacists function in many areas within the pharmacy department. Clinical Pharmacists perform the clinical review of medical and outpatient pharmacy Utilization Management (UM) cases, using their clinical acumen and benefit information into consideration when issuing a ...
Sacramento1 day ago
-
Revvity's Detection team services the Pharmaceutical, Academic, Government, Biotechnology, and CRO end markets. Solutions include AlphaLISA, HTRF, LANCE, DELFIA and Luminescence drug discovery reagents; Multimode Plate Readers; Microplates and imaging reagents. The Field Applicat ...
Sacramento $120,000 - $130,000 (USD)5 days ago
-
Job Posting: Environmental Scientist · Department of Food & Agriculture · JC-502717 · Environmental Scientist · ENVIRONMENTAL SCIENTIST · $4, $9,321.00 per Month · New to State candidates will be hired into the minimum salary of the classification or minimum of alternate range wh ...
Sacramento $4,418 - $9,321 (USD)3 days ago
-
+75% of work outdoors doing sampling inspectionsJob summary: Environmental Scientist will sample analyze results of commercial feed livestock drugs conduct environmental impact studies take regulatory actions conduct investigations inspections other duties enforcement CA laws. · ...
Sacramento $4,418 - $9,321 (USD)1 month ago
-
The Warehouse Associate assists in day-to-day operations of the warehouse by performing stock control duties including receipt storage retrieval ensuring timely delivery of goods. · * High school diploma or equivalent* 2+ years experience in a warehouse environment* Experience in ...
Sacramento $19 - $21 (USD)3 weeks ago
-
The Manager, Pharmacy Care Delivery will be responsible for providing pharmaceutical care and drug therapy to patients. This includes managing productive relationships with care providers and members, leading teams workflow and execution of comprehensive pharmaceutical informatio ...
Sacramento3 weeks ago
-
+MFCP (Motion & Flow Control Products, Inc.) is the largest Parker Hannifin distributor and the premier unrivaled leader in motion and flow control solutions. · +Receive products, including unloading. · Verify incoming product & receive into system. · <liAllocate distribute pull/ ...
Sacramento $19 - $23 (USD)3 weeks ago
-
The Warehouse Associate is responsible for assisting in day-to-day operations of the warehouse. · This includes stock control, along with receipt, storage, retrieval and ensuring the timely delivery of goods. This role also helps to organize shipment loading and transferring and ...
Sacramento $19 - $21 (USD) Full time3 weeks ago
-
+Job Summary · The Material Handler ensures the efficient handling, storage and distribution of pharmaceutical materials and products for Orca's cell therapy products. · +Receive, inspect and verify incoming materials against orders and documentation · Maintain accurate inventor ...
Sacramento $21 - $29 (USD) Full time3 weeks ago
-
Job summary · We have built a state-of-the-art manufacturing facility in Sacramento CA to ensure consistent delivery of our high-precision cell therapy products. · The Material Handler ensures efficient handling storage distribution of pharmaceutical materials products ensuring a ...
Sacramento $21 - $29 (USD)3 weeks ago
-
The Material Handler ensures the efficient handling, storage and distribution of pharmaceutical materials and products for Orca's cell therapy products. · Receive, inspect and verify incoming materials against orders and documentation · Maintain accurate inventory records, perfo ...
Sacramento $21 - $29 (USD)3 weeks ago
-
This Sacramento CA based Interventional Capital Sales Representative is responsible for the promotion and sales of designated products in such a manner as to increase sales in their given territory. · ...
Sacramento $70,000 - $200,000 (USD) Full time1 week ago
-
PNNL seeks a creative and inter-disciplinary power system engineer to develop model enhancements for conventional power system models (primarily production cost models and expansion planning models) to represent changing system constraints and dependencies imposed by the rapid gr ...
Sacramento1 month ago
-
This Sacramento CA based Interventional Capital Sales Representative is responsible for the promotion and sales of designated products in such a manner as to increase sales in their given territory. · The incumbent is responsible for the growth of overall product utilization with ...
Sacramento $70,000 - $200,000 (USD)1 week ago
- Work in company
Part-Time Forklift Operator - Monday thru Friday, 2PM to 7PM - 20.50/Hour (Sacramento, CA)
Only for registered members
We are hiring a Part-Time Power Equipment Operator to join our team and help us build the best Scholastic book fairs in Northern California. · ...
Sacramento Part time1 month ago
Quality System Specialist, Sterile Drug Products - Sacramento - Kelly
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.
Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly.
Position Title: Quality Management Systems Specialist, Sterile Drug Products
Position Type: Direct hire
Salary Range: 70,000-80,000/year
Benefits:
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:
What You Bring:
Preferred Skills:
Additional Information:
Why Sacramento? Why Us?
Ready to elevate your quality career and drive innovation at the forefront of Sacramento's pharmaceutical industry? xhmxlyz Apply today and lead the way in parenteral QMS excellence
-
Quality System Specialist, Sterile Drug Products
Only for registered members Sacramento
-
Quality System Specialist, Sterile Drug Products
Kelly- Sacramento
-
Quality System Specialist, Sterile Drug Products
Only for registered members Sacramento, CA
-
Director, Regulatory Affairs
Only for registered members Sacramento
-
Ambulatory Care Pharmacist
Only for registered members Sacramento
-
Clinical Pharmacist
Only for registered members Sacramento
-
Field Application Scientist
Only for registered members Sacramento
-
environmental scientist
Only for registered members Sacramento
-
environmental scientist
Only for registered members Sacramento
-
Warehouse Associate
Only for registered members Sacramento
-
Manager, Pharmacy Care Delivery, Outpatient Pharmacy
Only for registered members Sacramento
-
Warehouse Associate
Only for registered members Sacramento
-
Warehouse Associate
Full time Only for registered members Sacramento
-
Material Handler, 3rd Shift
Full time Only for registered members Sacramento
-
Material Handler, 2nd Shift
Only for registered members Sacramento
-
Material Handler, 3rd Shift
Only for registered members Sacramento
-
Interventional Capital Sales Rep
Full time Only for registered members Sacramento
-
Power Systems Research Engineer
Only for registered members Sacramento
-
Interventional Capital Sales Rep
Only for registered members Sacramento
-
Part-Time Forklift Operator - Monday thru Friday, 2PM to 7PM - 20.50/Hour (Sacramento, CA)
Part time Only for registered members Sacramento