The Quality Assurance Line Inspector performs line inspection as part of the cGMP, SOP and policy compliance requirements. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly-organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action. The primary responsibilities required for this role are:
Essential Job Functions
- Reads and understands approved specifications/standards assigned to the project
- Directs personnel assigned to the specific production line, concerning the quality attributes to be adhered to and monitors attire of personnel for adherence to cGMPs.
- Determines the need and executes the halting of operations due to adverse quality conditions in an effective and timely manner.
- Performs final review and approval of line clearance activities.
- Collects and inspects samples as required; inspects product for correctness, performs weight checks, torque checks, vacuum chamber tests, lot code resistance testing, collects retain samples and packages and documents as required, etc.
- At the assembly lines conducts quality inspections, including but not limited to inspection of the assembly line for cleanliness, use of correct components, use of correct labels; including correct label placement, condition of components and labels, overall product quality and cleanliness, use of correct lot code methodology
- Performs in-process quality testing in manufacturing and/or packaging areas according to prescribed timelines, and accurately captures test results in batch records.
- Objectively reviews, audits, and monitors the processes for adherence to quality, cGMP and product specification standards from the time a production run starts-up, though to its completion against approved quality document or record.
- Performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP’s
- Communicates with Management, Production, and Planning regarding questionable measurements, non-conformance issues, consistency, and overall product quality.
- Consistently records quality related results in accordance with prescribed good documentation practices requirements and data is accurately reported.
- Visually verifies the completion of all steps in-process and strictly adheres to company policies and procedures
- Cleans up work following the completion of a shift.
- Must be able to work extended hours as needed and occasional weekends.
- Other duties and responsibilities as assigned.
Knowledge, Skills & Abilities:
- Must be able to distinguish different shades of colors.
- Requires the ability to read, write, understand and communicate in English
- Comprehend and follow written and oral instructions
- PC-based computing experience (Word, Excel)
- Possesses basic math skills and an attention to detail
- Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP,GLP, documentation) when performing the assigned activity.
Education & Experience
- Minimum of 3+ years of experience in a QA Inspector within a nutritional supplements, food, consumer products or pharmaceutical company.
- High School diploma is required; BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.