What are the responsibilities and job description for the Quality Assurance Auditor I position at Careerbuilder-US?
Responsibilities :
- Responsible for collecting, assembling, and managing information and making appropriate decisions on approval or rejection for all components, drug product containers, in-process materials, packaging materials, labeling, and drug products manufactured.
- Responsible for conducting Foreign Matter Investigations as needed for materials throughout the lifecycle of the receipt, sampling, testing, dispensing and other in-process stages of material use.
- Responsible for receipt, log in and management of incoming retains and in-house retains. This includes management of annual inventory, annual product reviews and destruction of materials which have exceeded expiry.
- Responsible for serving as a QA “first responder” for various issues that occur on the manufacturing / packaging floor and / or during batch record documentation / review and providing directions for situations of low complexity; moderate to high complexity situations must be deferred to more senior QA personnel.
- Responsible for labeling issuance, review and / or returns; document processing including data entry, data verification and / or processing / controls of documentation.
- Responsible for participating in investigations and providing recommendations for corrective actions and prevention of recurrence.
- Responsible for writing, revising or reviewing Standard Operating Procedures (SOP’s), forms and / or Work Instructions with changes of low complexity and responsible for ensuring accuracy and GMP compliance in documents that are being reviewed such as artwork, raw material files, AQL inspection forms, and labeling.
- Responsible for performing additional related duties as assigned.
