Supervisor, Quality
Description
Quality Supervisor
The Quality Supervisor oversees the department dedicated to compliant, efficient internal quality systems and procedures related to the packing of drug substances and drug products for customers. Quality systems include, but are not limited to: Batch Review, Component Release, Product Complaints, Training, Auditing, and Calibration. This role also supports The Company's safety programs at both site and network levels and is responsible for product safety, quality, and legality.
Primary Responsibilities
- Oversee quality functions for display and packaging operations, including:
- Batch Record Review
- FDA Regulated Labeling
- First Piece and In-Process Inspections
- Quality Investigation Reports (QIRs) with Root Cause Analysis
- Corrective and Preventive Actions (CAPAs)
- Change Controls
- Periodic Product Reviews
- Consumer Complaints
- Quality Management System (QMS) Gap Analysis
- Provide compliance guidance for display/promotional packaging and FDA labeling
- Support Customer Product Recall and Quality Hold processes
- Ensure inspection readiness and compliance with customer QMS
- Recommend actions to maintain quality standards and minimize risk
- Facilitate use of unreleased product with customer approval
- Support quality goals, metrics, and strategic initiatives
- Act as liaison with customer supply planners
- Conduct internal Level I audits and SOP reviews
- Train Quality Department and facility staff as subject matter expert
- Support continuous improvement via Operational Excellence principles
- Implement and maintain The Company Safety Management System
- Lead site Safety Committee and related programs
- Demonstrate advanced knowledge of FDA standards and GMPs
- Work independently and manage multiple projects effectively
Education & Experience
- Bachelor's Degree or equivalent in a related field
- Minimum 3 years in a quality/compliance role
- Validation experience (IQ/OQ/PQ) preferred
- Knowledge of healthcare regulations preferred
- Experience with ISO standards preferred
- Familiarity with FDA regulations and facility operations required
- Certified Internal Auditor (CIA) or auditing experience preferred
- ASQ quality certification preferred
- Office and on-site work required, with travel across North America
Requirements, Perks, and Benefits (US -- Exempt)
Physical & Cognitive Requirements (With or Without Accommodation)
- Ability to follow policies and procedures.
- Ability to read, write, and interpret information.
- Ability to add, subtract, multiply, and divide.
- Ability to use hands to finger, handle, or feel.
- Ability to sit, walk, or stand for the duration of the shift.
- Must possess visual acuity to perform essential job functions.
- Ability to conduct physical tasks with a full range of motion throughout the warehouse environment.
- Ability to lift/carry items up to 50 pounds.
Equal Opportunity Employer
FedEx Supply Chain, Inc. is an Equal Opportunity Employer, including veterans and individuals with disabilities.
- Know Your Rights
- Pay Transparency
- Family and Medical Leave Act (FMLA)
- Employee Polygraph Protection Act
E-Verify Program Participant
Federal Express Corporation participates in the Department of Homeland Security U.S. Citizenship and Immigration Services' E-Verify program (for U.S. applicants and employees only). Please click below to learn more:
FedEx Supply Chain is committed to providing access, equal opportunity, and reasonable accommodation for qualified individuals with disabilities in its application procedures, hiring, and other terms and conditions of employment. To request a reasonable accommodation, please contact FSC.TalentAcquisition@fedex.com.
Perks and Benefits at FedEx Supply Chain (FSC)
- Competitive Pay: Competitive wages depending on your location and experience, paid bi-weekly for both full-time and part-time opportunities.
- Tuition reimbursement program
- Holiday pay and accrued paid time off programs offering both Vacation and PTO
- Medical, dental, vision, and voluntary benefits available on day one
- Basic life insurance
- Basic AD&D coverage
- Supplemental Life and Supplemental AD&D
- Short-Term and Long-Term Disability coverage for full-time employees after 180 days of service
- Paid parental leave for both moms and dads
- Paid bereavement and jury duty
Note: Pay is based on several factors including, but not limited to, market location and may vary depending on job-related knowledge, skills, education/training, and a candidate's work experience.
Job Disclaimer (US)
Please note that this job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the position. The Company reserves the right to modify duties or assign additional responsibilities as necessary to meet business needs.
