Supervisor, Quality Healthcare (2nd Shift)
Requisition ID: 21642
About FedEx Supply Chain
FedEx Supply Chain, a subsidiary of FedEx Corp. (NYSE: FDX), is a leader in the third-party logistics industry offering a diverse service portfolio that enables commerce for businesses. With a proven track record of innovation and operational excellence, FedEx Supply Chain takes a consultative approach to optimize logistics processes, implement innovative technology and drive continuous improvement. By leveraging best practices and the world-renowned FedEx network, FedEx Supply Chain delivers leading solutions that provide flexibility, enable scalability and improve cost-effectiveness for customers. Through more than 11,000 employees, 130 operations and 35 million square feet of warehouse space, FedEx Supply Chain manages nearly 150 million packages and processes 358 million returns each year. For more information, go to supplychain.fedex.com.
- A strong FedEx brand consistently ranked among the world’s most admired and trusted employers.
- A top notch leadership team with the experience needed to grow and develop your career.
- An open mind for new ideas and creative methods.
- A strong compensation and benefits package, including health, vision, dental, 401k with a strong match and much more!
The Quality Healthcare Supervisor oversees the 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 Supervisor also supports The Company’s safety programs both at a site and network level. This position is responsible for product safety, quality and legality.
This position will be responsible for…..
- Oversee the quality function covering displaying and packaging operations, including but not limited to the following processes:
- Batch Record review
- FDA regulated labeling
- First piece inspection and in-process inspection
- Quality Investigation Reports (QIRs) including Root Cause Analysis
- Corrective Actions, Preventive Actions (CAPAs)
- Change Controls
- Periodic Product Reviews
- Consumer Complaints
- QMS (Quality Management System) Gaps
- 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.
- 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.
- Support internal Level I audits and SOP reviews in accordance with the published schedule as defined in local auditing procedures.
- 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 within a functional group or packaging site.
- Implement / Maintain The Company Safety Management System.
- Head site Safety Committee and related programs.
- 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.
- Works independently and adapts quickly and resourcefully to changing situations and business needs while managing multiple projects meeting specific goals and deadlines.
You might be a great fit if….
- Bachelor’s Degree or equivalent in a related field.
- At least five (5) years’ experience in supervisory QA/Compliance
- Validation experience (IQ/OQ/PQ) is desired.
- Knowledge of healthcare regulations and requirements, preferred.
- Experience certifying sites to ISO standards, desired
- Must be involved in the operations of the facility and be familiar with pertinent FDA regulations.
- Six Sigma Green Belt Certification is a plus.
- Certified Auditor or external supplier auditing experience is a plus.
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/stand for up to 10 hours per day.
- Ability to intermittently crawl, squat, climb, twist, bend, stoop, push or pull.
- Must possess visual acuity, i.e., close, distance, and color vision, depth perception and the ability to adjust focus.
- Ability to lift/carry items less than 20 pounds.
ADA – FedEx Supply Chain will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. Reasonable accommodations are available for qualified individuals with disabilities throughout the subsequent application process.
Fed Ex Supply Chain is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Job ID: 21642