Senior Quality Operations Specialist Job at Fullscript (Phoenix)

Job Description

The Senior Quality Operations Specialist is an experienced quality professional responsible for ensuring that the distribution center(s) comply with applicable current good manufacturing practices and regulations. The Senior Quality Operations Specialist will perform on-site quality activities and cGMP enforcement at the distribution center(s), and will act as the initial quality liaison and contact point for operations personnel, and other internal and external stakeholders. The Senior Quality Operations Specialist is required to build and foster positive working relationships within the distributor center(s) and quality team to drive quality management system and product safety compliance. The Senior Quality Operations Specialist supports all Fullscript DC facilities by leading cross-functional teams and projects to drive enterprise wide quality initiatives.

Job Responsibility

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

Requirements

+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%

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Senior Quality Operations Specialist

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