QA Specialist I
Title: QA Specialist I
Location: North Chicago, IL
Pay: $25-30/hr
Contract: 12+ months
Purpose:
Perform sampling, inspecting, and physical testing of incoming commodities per appropriate product specification in a laboratory environment. Applies scientific knowledge to daily operations, data management, and problem solving. Understands and follows documentation. Analyzes basic/simple data, evaluates results, forms conclusions, and recommends process and/or document improvements. Recognizes deviation from normal operating procedures. Recognizes and troubleshoots instrumentation and/or work order problems and routine operational issues.
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 is required.
- 4+ years of overall work experience
- Computer skills proficiency including word processing, spreadsheets, instrumentation related and Company 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.
- Have an understanding of material/product traceability and Device History Records