QA Specialist I
503 Vandell Way Campbell, CA 95008 US
Job Description
Job Description:
Performs inspection, review, and approval of incoming commodities, test reagents, and raw materials per appropriate product specification and procedural requirements. Applies scientific knowledge to daily operations, data management, and problem solving. Understands and follows documentation and standard operating procedures. Analyzes basic/simple data, evaluates results, forms conclusions, and recommends process and/or document improvements. Recognizes non-conformances from normal operating procedures. Recognizes and troubleshoots problems and routine operational issues. Performs training on procedures and protocols in support of activities performed. Participates in Company Safety and Quality improvements.
Responsibilities:
Responsible for inspection, review, and approval of incoming commodities, test reagents, and raw materials per appropriate product specification and procedural requirements for performing routine testing on incoming materials in accordance with approved specifications and procedures.
Responsible for Disposition incoming materials for use in Manufacturing and Quality Control.
Responsible for Quality Unit review and approval of executed GMP documentation.
Responsible for controlled documentation issuance for Operations GMP activities.
Responsible for filing, inventory and tracking of GMP Documentation.
Responsible for maintaining the Document Control Center and inventory of files.
Maintains certification in assigned job responsibilities and completes training on-time.
Participates in complaint handling, failure investigations, and CAPA documentation.
Understands, implements, and maintains the quality policy and ensures compliance to site level policies and procedures.
Develops knowledge of products and technologies. Interacts on a necessary basis with internal and external support groups to perform core skills.
Participates in team activities and area metric tracking.
Responsible for supporting Operations efforts in meeting established production schedule.
Reports problems in a timely and accurate manner.
Seeks additional guidance or advice when problem is beyond scope of training or knowledge.
Qualifications:
High School Diploma required; Bachelor’s degree preferred.
Good understanding of basic math.
Good clerical skills are required.
4+ years of overall work experience
Computer skills proficiency including word processing, spreadsheets, instrumentation related and network systems.
Previous experience in Quality Assurance
2+ Experience in a manufacturing/finishing environment is desired.
Previous knowledge of GMP regulations and standards affecting pharmaceutical products is desired.
Understanding of material/product traceability and Device History Records is desired.
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