Second level position with training in statistical sampling and inspection of incoming materials, filled products, packaged products, and processes for conformance to approved written specifications, SOPs, cGMPs, and FDA regulations. Requires training in physical testing. Will perform sampling and inspection without constant supervision and operate some technical equipment with training.
Essential Duties and Responsibilities of this position include but are not limited to:
- Performs physical testing of components with supervision from an experienced quality control analysts or Device Laboratory management.
- Reports any problems found during inspection to Device Laboratory management.
- Samples and inspects components, drug product containers, packaging and labeling according to approved written material specifications, engineering drawings, artwork, and specimen labeling.
- Samples and inspects products for each new batch per product specifications to assure the identity, quality, and trace ability of incoming product materials according to current SOPs and test reports.
- Follows GMP documentation practices in manufacturing, laboratory, and packaging batch records.
- Accompanies Analysts III or IV in performing room inspections, in-process checks, and verifications for various production and laboratory areas and equipment.
- Accompanies Analysts III or IV in performing sampling for laboratory control testing, stability testing, and other special purposes.
- Understands and recognizes product status such as Approved, Hold, Rejected, etc.
- Reviews manufacturing, laboratory, and packaging batch records.
- Understands Good Manufacturing Practice regulations.
- Understands and utilizes ANSI sampling plans
- Recognizes and reports problems and adverse quality events to Device Laboratory management.
Knowledge Necessary to Perform the Job:
· Knowledge of 21 CFR 210 and 211 cGMPs and part 11 to determine materials’ disposition.
· Knowledge and understanding of ANSI sampling plans
• Associates Degree or higher preferred but not required
• Minimum 3-5 years’ experience as a Quality Control Analyst in a manufacturing environment
• Must have experience working in a fast paced environment
• Must be able to read and follow SOPs exactly
• Must be able to stand for entire shift and be able to reach with hands/fingers to touch products for inspection
• Must be able to lift and or move up to 25 pounds, on occasion
• Must be able to pass a vision test, and with both eyes test at 20/25
• Must be able to multi-task and work under time and production deadlines
• Strong analytical and problem solving skills
• Self-Motivated with a proven record of taking the initiative
• Exercise sound judgment and ability to work effectively with a diverse workforce