Quality Systems Manager

Cart.com•Temecula, CA

1d•Onsite

About The Position

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.

Requirements

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
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 21CFR 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
Must be able to work in extremely cold storage environments (-90°C to 20°C) for extended periods.
Ability to lift up to 50 lbs. occasionally and withstand constant physical activity (standing, walking, bending, stooping).
Willingness to work flexible hours, including nights, weekends, and overtime as needed.
Exposure to heavy machinery, conveyors, and changing environmental conditions.
Must follow strict safety and operational protocols to ensure compliance and efficiency.

Nice To Haves

Certifications in ISO 9001, Lean Six Sigma, or related quality assurance fields.
Experience working in multi-temperature warehouses (-90°C to ambient temperatures).
Knowledge of continuous improvement methodologies.
Designated Representative experience

Responsibilities

Supervise and enforce quality control procedures throughout fulfillment and cold storage operations in one of our Life Sciences fulfillment centers.
Ensure compliance with industry regulations, internal policies, and safety standards.
Conduct routine inspections and audits of inbound and outbound shipments, storage areas, and handling processes.
Maintain and oversee proper documentation and record-keeping for audits, inspections, and compliance reporting based on 21 CFR 210 & 211 standards.
Own site-level Change Control, CAPA, and Exception Event processes, ensuring timely execution and closure while supporting new client onboarding and network-level quality alignment.
Oversee environmental monitoring systems in deep cold storage (down to -90°C) as well as CRT (-15C to –25C) to ensure ongoing compliance, validation support, and documented review of storage conditions.
Investigate and report any deviations in temperature protocols and work with operations to take corrective actions.
Ensure adherence to handling procedures for materials stored in multi-temperature environments.
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.
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.
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).