Senior Quality Operations Specialist
Phoenix, AZFull-TimeSeniorOperations
Skills
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.
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%
