What are the responsibilities and job description for the Quality Assurance Specialist I , North Chicago , IL position at Systems Ally?
W2 only no C2C or third party
NOTES:
2 yrs Manufacturing/quality exp if degree
4 yrs exp in QA/Manufacturing if no degree
Recent grad with internship exp ok
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 client 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
