Quality Assurance Supervisor

About the role

The Supervisor, Quality Inspection will hold a key position in the Quality Department. The individual is responsible for a variety of Quality Management duties including direct supervision of the Quality Inspector and providing on-the-ground support at our 3rd party logistics provider in Plainfield, IN.

Responsibilities

• Affirms responsibility for establishing and maintaining effective, coordination, communication and professional business relations with suppliers, company personnel, management and 3PL.
• Performs Quality Inspection of product receipts and release documentation for conformity to specifications and disposes of product.
• Provides clear direction and supervision of the Quality Inspector.
• Reviews transaction and exception reports to assure 3PL transactions exactly match transactions authorized through SAP.
• Notifies 3PL and Quality if transactions are missing or unauthorized transactions have been keyed to resolve discrepancies.
• Inspects product returns and determines what may or may not be returned to stock based on SOP and acceptance criteria.
• Reviews Certificates of Analysis and Conformance to assure compliance with specifications.
• Communicates with suppliers to obtain corrected or missing certificates.
• Conducts nonconformance investigations to determine cause and initiate CAPAs as required.
• Supervises and shares workload with Quality Inspector to ensure timely completion of job duties.
• Occasionally supervises and inspects rework/relabel operations to correct non-conformances.
• Completes and maintains related inspection reports and documentation in an organized and retrievable manner.
• Aids Quality Managers in updating and generating SOPs to improve GMP compliance at 3PL.
• Protects organization's competitiveness by keeping information confidential.
• Accomplishes organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.

Qualifications

• Associate Degree with 2 years relevant experience.
• Previous experience with quality and packaging inspections.
• Experience with SAP or other ERP systems in a GMP environment.
• Knowledge of FDA cGMP for Warehousing and Distribution, Packaging and Labeling, and Returned and Salvaged Products.
• Strong Knowledge of ISO 13485:2016.
• Strong verbal and written communication skills are required.
• Proficiency in computer skills, Microsoft Office applications (Excel/Word).
• Efficient and attentive to detail.

Essential Physical Functions

• Basic office activities.
• Approximately 60/40 split between active inspection work in the warehouse and office work.
• Exerts up to 40 lbs. of force occasionally (ability to move cases from pallets for inspections and ability to walk back and forth from office to warehouse storage locations).
• Equipment Used: Computer, Printer.
• Travel: 5% ability to travel via car, plane, rail.

Work Environment

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The noise level in the work environment is usually moderate.
• No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Work Schedule

All applicants must be able to work in our Geodis Warehouse – Monday through Friday. Work Hours: 40 hours per week.

Compensation Range

$65,000.00 - $75,000.00 annually