Quality Inspector -Sampling and Inspection

UPM Pharmaceuticals, a mid-sized contract drug development and manufacturing company, located in Bristol, Tennessee is seeking a Quality Inspector 1.

Summary:

Position with training in statistical sampling and inspection of incoming materials, packaged products and processes for conformance to approved written specifications, SOP's, cGMPs, and FDA regulations. Requires physical testing training. Is able to perform sampling and inspection with minimal supervision.

Essential Duties and Responsibilities:

1. Performs sampling of raw materials for laboratory Quality Control testing, stability testing and other special purposes.

2. Samples and inspects all packaging components, including drug product containers, closures, and labeling according to effective written material specifications, drawings, and artwork.

3. Performs sampling of bulk product.

4. Maintains retain sample area and prepares materials for destruction.

5. Inspects retain materials for Annual Product Reviews.

6. Reports any problems found during inspections to Quality Assurance management.

7. Follows cGMP documentation practices.

8. Labels materials with appropriate product status labels.

9. Understands and recognizes product status such as Approved, Hold, Rejected, etc.

10. Understands and follows current Good Manufacturing Practice regulations.

11. Understands and utilizes ANSI sampling plans.

12. Recognizes and reports problems and adverse quality events to quality management.

13. Other job duties as assigned.

Knowledge Necessary to Perform the Job:

1. Knowledge of 21 CFR Parts 210 and 211.

2. Knowledge of all applicable quality, manufacturing, packaging, and multi departmental SOP's in order to perform duties.

Education/Experience:

HS/GED and one year related experience and/or successful completion of a job-specific training program or equivalent combination of education and experience.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Relocation assistance
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Relocate:

• Bristol, TN 37620: Relocate before starting work (Required)

Work Location: In person