Quality Control Operator - Preanalytics

Quality Control Operator I PreAnalytics

Responsibility:

• Carry out QC testing and examination according to valid procedures.
• Carry out Incoming Goods Inspection according to valid procedures
• Preparation of solutions and equipment for production according to valid TP’s and SOP’s as required
• Cleaning and sanitation of Laboratory / QC areas
• Perform QC Inspections on the Manufacturing floor
• Issue a QIR for non-conforming product.
• Test non-conforming product to resolve QIR issue’s as well as investigate returned products via complaint processing system.
• Perform equipment calibration.
• Perform routine inventory (e.g., chemicals, supplies, etc.) for lab.
• Assist in maintaining inventory database and SAP inventory
• Assist in ordering chemical and lab supplies.
• Other duties as assigned.
   

Authority:

• Evaluation of products in the production according to valid QMI documents.
• Restriction of non-conformity product according to appropriate QMI documents.
• Release of product according to valid QMI documents.
• Release incoming goods according to valid Certificate of Analysis (e.g., Nipro, BCA, EDTA, Safety Blood Collection Set).
• Release sterilization.
• Release of solutions.
• Perform SAP transactions to Hold and release 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.
   

Physical Requirements:

• Must be able to stand and walk for up to 8/12 hours.
• Must have appropriate vision to perform detailed quality inspection as outlined in SOPs and TPs.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, sex, sexual orientation, gender identity, genetic information, age national origin, veteran status, physical or mental disability or any other characteristics protected under applicable federal, state or local law.