Fullscript · 12 hours ago
Senior Quality Operations Specialist
Fullscript is an industry-leading health technology company on a mission to help people get better. The Senior Quality Operations Specialist is responsible for ensuring compliance with current good manufacturing practices at distribution centers, performing quality activities, and fostering positive relationships to drive quality management and product safety compliance.
Health CareInternetMedicalPersonal HealthWellness
Responsibilities
Maintain sanitation, hygiene and housekeeping program of the distribution center to meet cGMP and regulatory requirements
Perform regular DC inspections and follow-up actions to correct and prevent non-conforming issues, and escalating concerns to the Quality Operations Manager as needed
Ensure that sanitation, hygiene and housekeeping procedures and records are adequate and suitably maintained
Administrator critical environmental control systems supporting all facilities
Ensure that temperature / RH controls of the distribution center meet cGMP and regulatory requirements, and that temperature / RH procedures and records are adequate and suitably maintained
Coordinate pest control activities for the distribution center to ensure compliance with cGMP and regulatory requirements
Maintain pest control procedures and records
Oversee product returns and product disposition decisions at the distribution center(s) to ensure compliance with established requirements and timely and effective handling
Ensure that product returns & disposition procedures are records are adequate and suitably maintained
Oversee the preventive maintenance and calibration program to ensure that all critical equipment that may affect the quality and safety of the product is suitably maintained to meet established requirements
Maintain preventive maintenance procedures and records
Provide cGMP and cGDP training for new hires and refresher training annually for all distribution centers employees, and ensure completion of training records
Assist employees with understanding quality assurance policies and cGMP procedures
Perform internal quality audits and/or product verification audits as per internal audit procedure requirements
Complete internal audit reports and follow-up on non-conforming issues to drive correction and prevention of issues, and escalating concerns to the Quality Operations Manager as needed
Support external quality / regulatory audits
Working closely with distribution center management and quality management ensures site readiness, coordinates documentation/record availability, and ensures a suitable facility environment to support successful audits
Perform document change control and training activities in the Fullscript eQMS
Ensures document changes are suitably controlled and compliant within the eQMS and that the necessary approvals and training are completed
Lead cross-functional teams and projects to drive quality initiatives
Support product recalls, product quarantine directives, and customer complaint activities as needed
Support system verification and validation activities as needed
Additional quality-related duties may be assigned as needed
Qualification
Required
+5 years of quality-related experience in a food / dietary supplement warehousing and distribution facility
PCQI or similar Food Safety certification
A good understanding of cGMP requirements, specifically 21CFR111 / 21CFR117
Meticulous attention to detail, superior organizational capabilities, and a keen investigative approach are crucial
Proactive self-starter with the ability to concentrate and drive tasks to completion autonomously
Exceptional verbal and written communication skills are required for effective dissemination of information and collaboration with colleagues across all organizational levels, as well as potential interactions with regulatory agencies
Proficiency in Google Suites and/or Microsoft Office applications
Working knowledge of Warehouse Management Software e.g., HighJump
Ability to work independently within a warehouse environment
Must be willing to travel 10-20%
Company
Fullscript
Fullscript is a supplement dispensing platform and patient adherence tool that supports practitioners at the point of care and beyond.
Funding
Current Stage
Late StageTotal Funding
$267MKey Investors
Leonard Green & PartnersHGGC,Snapdragon Capital PartnersKayne Anderson Growth Capital
2025-05-05Private Equity
2021-11-09Private Equity· $240M
2019-05-21Series B· $25M
Recent News
2026-02-03
2026-01-16
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