Inspector Night Shift

POSITION/TITLE:  Quality Assurance (QA) Inspector

DEPARTMENT:  Quality Assurance

REPORTS TO:  QA Manager

DUTIES/RESPONSIBILITIES:

• Inspects all batch documentation prior to filling & packaging on production line
• Inspects and verifies against Bill of Material (BOM) that correct packaging components, bulk material, and labels are used on the line
• Verifies that bulk material, packaging components, and labels have been approved for use.
• Monitors fill weight/volume of products being filled & packaged
• Audits for compliance with finished product packaging specifications found in the batch production record and applicable SOP’s
• Submits bulk tank and finished product samples to the Quality Control (QC) Laboratory for physiochemical, chemical, and microbial testing
• Audits batch record documentation for completeness, correctness, and compliance with Current Good Manufacturing Practice (cGMP) as found in 21 Code of Federal Regulations (CFR) 210 & 211
• Monitors all personnel for adherence to cGMP requirements
• Monitors the packaging line & surrounding area for cGMP cleanliness compliance and absence of clutter
• Assist in the inspection of each packaging component after receipt of each shipment and documents the findings
• Performs additional duties as assigned by supervisor

• Minimum high school graduate.  Some college preferred
• Some QA/QC experience in a FDA regulated manufacturing environment preferred
• Basic math skills required
• Good oral and written communication skills in English
• Ability to keep accurate records
• Ability to follow documented procedures and standards
• Good time management skills with the ability to work independently with some supervision
• Ability to walk and/or stand & work entire shift on your feet
• Ability to work safely around machinery
• Ability to frequently lift 25 pound objects
• Ability to multi-task in a fast-paced environment to assure delivery requirements
• Excellent time management skills with the ability to work independently with little supervision
• Ability to meet and monitor deadlines and prioritize work
• Self motivated and detail oriented
• Must be able to stoop, reach, sit or stand up for up to eight hours