Senior Quality Operations Specialist

Fullscript • Phoenix, AZ

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About The Position

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.

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%

Responsibilities

• Sanitation / Hygiene / Housekeeping:
• 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.
• Temperature / Humidity Controls:
• 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.
• Pest Controls:
• Coordinate pest control activities for the distribution center to ensure compliance with cGMP and regulatory requirements.
• Maintain pest control procedures and records.
• Product Returns & Disposition:
• 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.
• Preventive Maintenance & Calibration:
• 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.
• Training:
• 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.
• Internal Audits:
• 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.
• External Audits:
• Support external quality / regulatory audits.
• Working closely with distribution center management and quality management ensures site readiness, coordinates documentation/record availability, and ensuresa suitable facility environment to support successful audits
• eQMS Document and Training Control:
• 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.
• General:
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed