Responsibilities :
- Responsible for performing routine testing on incoming materials in accordance with approved specifications and procedures.
- Disposition incoming material for use in manufacturing.
- 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.
- years of overall work experience.
- Computer skills proficiency including word processing, spreadsheets, instrumentation related and network systems.
- Previous experience in Quality Assurance.
- Experience in a manufacturing / finishing environment is desired.
- Previous knowledge of GMP regulations and standards affecting pharmaceutical products is desired.
- Have an understanding of material / product traceability and Device History Records.
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