Quality Systems Manager

* This position is open to applicants or individuals who are located in or around the  
** Temecula, CA*
* ** area
* * and is an Onsite role with possible infrequent travel required.
**
* The Role:

** As a Quality Systems Manager, you will play a critical role in maintaining the  highest standards of operational quality, compliance, and efficiency for the Temecula cold storage fulfillment facility. You will oversee quality control  processes, ensure adherence to cGMP and company standards, and work closely  with operations teams to implement continuous improvement initiatives. In  addition to local oversight, you will own site-level QMS processes including  change control, CAPA, validation support, document lifecycle management, and  audit readiness.

Your role is essential in ensuring both day-to-day operational  compliance and structured quality system execution as we onboard additional  clients and expand site responsibilities.  
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* What You’ll Do:

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* ** Quality Assurance & Compliance:
**** Process Improvement & Training:
*** Develop and implement standard operating procedures (SOPs) for quality control and assurance.
* Provide training and coaching to warehouse associates on proper handling procedures and quality standards.
* Collaborate with the Operations and Maintenance teams to drive continuous improvement initiatives to enhance quality and minimize errors.
** Incident Management & Problem-Solving:
*** Investigate and document quality issues, non-conformances, and corrective actions.
* Implement root cause analysis (RCA) and corrective action plans (CAPA) to mitigate risks and prevent recurring issues.
* Serve as the point of contact for internal and external audits, ensuring prompt resolution of any compliance concerns.
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* Cross-Functional Collaboration:

*** Partner with the warehouse, inventory, and fulfillment teams to maintain quality standards throughout all processes.
* Support maintenance teams in ensuring equipment and facility compliance with safety and operational standards.
* Work closely with leadership to develop quality performance metrics and track key performance indicators (KPIs).
** Who You Are:
*** You have strong knowledge of quality assurance, compliance, and operational best practices.
* You are detail-oriented, with a problem-solving mindset to identify risks and implement corrective actions.
* You have a deep understanding of computerized systems to include warehouse management software, temperature monitoring software, data backup software, etc.
* You have specific knowledge around IQ/OQ/PQ protocols, traceability matrices, validation reporting, user requirement specifications (URS), etc.
* You thrive in a fast-paced, high-volume fulfillment environment and can manage multiple priorities efficiently.
* You have excellent communication skills, able to collaborate with operations, maintenance, and compliance teams effectively.
* You are proficient in quality management systems (QMS), audit processes, and regulatory documentation, specifically in cGMP compliance and 21

CFR 210 & 211
* You demonstrate leadership qualities, mentoring and training teams to uphold quality standards.
* You have the ability to be the designated representative for our location answer to local governing bodies
** What You’ve Done:
** 5+ years of experience in quality assurance, compliance, or operational  quality roles, preferably in a cold storage, fulfillment, or warehouse  environment.
Experience conducting internal audits, inspections, and implementing  quality control measures.
Experience performing system validations across multiple platforms  making sure adherence to our quality expectations and company standards   Strong analytical skills and the ability to conduct root cause analysis and  develop corrective action plans.
Proficiency in Microsoft Office Suite, warehouse management systems  (WMS), and quality management software. Ability to train and educate teams on compliance standards and best  practices.
Ability to effectively interact with partners in IT, GRC, engineering, etc  
** Nice to Haves:
** Certifications in ISO 9001, Lean Six Sigma, or related quality assurance  fields.
Experience working in…