Quality Control Operator I BioScience

Responsibility:

• Carry out QC testing and examination according to valid procedures.

• Carry out Incoming Goods Inspection according to valid procedures.

• Perform QC Inspections on the Manufacturing floor.

• Issue a QIR for non-conforming product.

• Testing of non-conforming product to resolve QIR issue as well as investigate returned products via complaint processing system.

• Perform routine inventory (e.g., chemicals, supplies, etc) for labs.

• Assist in ordering chemical and lab supplies..

• Cleaning and sanitation of Laboratory / QC areas.

• Other duties as assigned.

Authority:

• Evaluation of products in the production according to valid procedures.

• Restriction of non-conforming product according to valid procedures.

• Release of product according to valid procedures.

• Release incoming goods according to valid Certificate of Analysis, TP’s and SOP’s as required. (e.g., raw materials, trays, labels).

• Release of sterilized product

• Perform SAP transactions to hold product

Job Requirements:

• High school education or equivalent; Degree is preferred with at least 1 year of relevant work experience.

• Experience in Medical Device, Pharmaceutical, and/or regulated industry is preferred

• Must have sufficient communication and writing skills.

• Must have been QC trainee for a period of 3 months.

• Must pass pre-employment test.

• Basic computer knowledge and MS Office skills.

• Operational knowledge of Computer Aided Quality (CAQ) inspection data base (i.e. BABTEC)

• Must be able to stand and walk for up to 8 to12 hours.

• Must be able to lift up to 70 lbs.

• Must have appropriate vision to perform detailed quality inspection as outlined in SOPs and TPs.

Physical Requirements:

• Must be able to stand and walk for up to 8/12 hours.

• Must be able to lift up to 70 lbs.

• Must have appropriate vision to perform detailed quality inspection as outlined in SOPs and TPs.