Sr. Supervisor, Quality Assurance

Job Title: Sr. Supervisor, Quality Assurance
Reports To: Sr. Director – Quality Assurance
Department: Science & Technology
 

JOB SUMMARY:
The Sr. 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 a 3rd party logistics provider in the Indianapolis, IN area. The Supervisor will ensure Good Manufacturing Practices (GMP) compliance by helping develop, execute, and continuously improve the Quality Assurance programs.

MAJOR RESPONSIBILITIES/ACTIVITIES:

• Assumes responsibility for establishing and maintaining effective, coordinated 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 dispositions product.
• Provides clear direction and supervision of the Quality Inspector.
• Reviews transaction and exception reports to ensure 3PL transactions match those authorized through SAP. Notifies 3PL and Quality if there are discrepancies.
• Inspects product returns to determine eligibility for restocking 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 corrective actions as required.
• Shares workload with the Quality Inspector to ensure timely completion of job duties.
• Supervises and inspects rework/relabel operations to correct non-conformances.
• Completes and maintains inspection reports and documentation in an organized and retrievable manner.
• Assists Quality Managers in updating and generating SOPs to improve GMP compliance at 3PL.
• Protects the organization’s competitiveness by maintaining confidentiality of information.
• Contributes to organizational goals by exploring opportunities to add value to job responsibilities.

QUALIFICATIONS:

• Bachelor's Degree with 2 years relevant experience.
• Previous experience with quality and packaging inspections.
• Experience with SAP or other ERP systems in a GMP environment.
• Ability to analyze information.
• 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.
• Proficiency in computer skills, including Microsoft Office applications (Excel/Word).
• Efficiency and attention 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 (able to move cases and pallets for inspection, and walk between office and warehouse locations).

Equipment Used: Computer, Printer

LANGUAGE SKILLS:
Ability to read, analyze, and interpret general business materials. Ability to write reports, business correspondence, and procedure manuals. Effectively present information and respond to questions from managers, clients, customers, and the general public.

MATHEMATICAL SKILLS:
Ability to calculate figures such as discounts, interest, commissions, proportions, and percentages. Apply basic algebra and geometry concepts.

REASONING ABILITY:
Apply common sense to carry out instructions in written, oral, or diagram form and solve problems with several concrete variables in standardized situations.

PHYSICAL DEMANDS:
Physical demands include the ability to stand, walk, use hands, reach, stoop, kneel, crouch, and occasionally lift/move up to 10 pounds. Requires specific vision abilities, including close vision and ability to adjust focus.

WORK ENVIRONMENT:
Moderate noise level typical of an office and warehouse environment. Reasonable accommodations can be made for individuals with disabilities.

Additional Information:

• No Sponsorship: Applicants must be authorized to work for any employer in the U.S. Sponsorship is not available.
• Work Schedule: Monday through Friday.
• Work Hours: 40 hours per week.

Salary and bonus:

• Salary range of $62,000 to $72,000
• Bonus eligible = 10% target