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The Quality/Safety Supervisor oversees a Quality Department dedicated to compliant, efficient internal quality systems and procedures related to packing of drug substances and drug products for customer. Quality systems include, but are not limited to: Batch Review, Component Release, Product Complaints, Training, Auditing, and Calibration. The Quality/Safety Supervisor also supports The Company’s safety programs both at a site and network level.
- Act as a subject matter expert performing training to the Quality Department and general facility as needed.
- Supports continuous improvement projects through understanding and execution of Operational Excellence concepts with a functional group or packaging site.
- Provide compliance guidance for display and promotional packaging and FDA regulated labeling.
- Supports Customer Product Recall process by overseeing product traces for products produced and consumed at the Northeast Display & Packaging Center.
- Supports Customer Quality Hold process by overseeing product traces and Quality Holds/Removals.
- Implement/Maintain The Company Safety Management System.
- Head site Safety Committee and related programs.
- All other duties and projects as assigned.
- Completes routine tasks with minimal supervision.
- Demonstrates advanced knowledge of FDA standards and quality systems.
- Demonstrates advanced knowledge of Good Manufacturing Practices (GMPs) Provide support as a subject matter expert or as needed in organization.
- Provide assistance to achieve compliance with customer QMS to ensure inspection readiness at all times.
- Propose actions in achieving and/or maintaining acceptable quality standards and the minimization of risk as defined by the customer QMS.
- Facilitate the use of unreleased product in packaging operations contingent upon customer’s approval of product.
- Support Quality objectives, goals, projects, metrics, performance standards and strategic initiatives as jointly defined by the customer and The Company.
- Act as a communication liaison with customer supply planners.
- Other compliance support as mutually agreed and approved between the customer & The Company.
- Support internal Level I audits and SOP reviews in accordance with the published schedule as defined in local auditing procedures.
- At least five years’ experience in supervisory QA/Compliance for a contract packaging facility.
- Bachelor’s Degree or equivalent in a related field.
- Validation experience (IQ/OQ/PQ)
- Six Sigma Green Belt Certification is a plus.
- Certified Auditor or external supplier auditing experience is a plus.
Vacancy Type: Full Time
Job Location: Columbus, MS, US
Application Deadline: N/A