Purpose and Scope
Under general supervision, is responsible for inspection, testing, record keeping and overall QA support of manufacturing, stability testing and clinical studies.
Essential Duties & Responsibilities
· Inspect materials, components, and finished product against specified requirements; follow procedures to determine status or disposition, and properly document results on records and in lab notebooks.
· Perform inspections on a variety of materials using measuring and test equipment.
· Support manufacturing and QA with inspections and material sampling.
· Understand and use the electronic document/documentation system in the performance of duties.
· Compile, review and maintain material history filed.
· Assist in clinical investigation product inspection and preparation for shipment to study sties.
· Control inventory of materials with “HOLD” status.
· Suggest improvements to streamline inspection and documentation processes and work with manufacturing department to assure success.
· Stability sample pulls only.
· Provide First Article and Finished Product inspections in support of manufacturing.
· Ensure proper status and storage of materials and product.
· Provide “hold status” materials requested to R&D, Pilot Production, Clinical, and Stability.
· Physical release of product form “hold” status.
· Perform various other duties as assigned.
Knowledge, Skills & Abilities
· Working knowledge in drug or device cGMP and ISO 9001 preferred.
· Skill in organization and attention to detail.
· Skill in computer operation; familiar with MS Word, Excel and Access.
· Ability to work independently.
· Ability to clearly communicate (oral & written) and work well with employees at all levels.
· Ability to read, understand and follow procedures.
· Ability to arrange workload to meet customer (internal & external) needs.
Education & Experience
· High school diploma or equivalent. Some college work in technical subjects helpful.
· Associate’s degree in technical subject preferred.
· Two or more year’s experience in the pharmaceutical or medical device industry in a Quality Assurance capacity.
· Manufacturing and Warehouse environment. Work may require occasional weekend and/or evening work.
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