Quality Control Operator II - PreAnalytics 2nd shift (with degree)

Job Title:

Quality Control Operator II - Preanalytics

Responsibility:

·      Perform according to valid procedures, as required:

  • Carry out Incoming Goods Inspection
  • Perform equipment calibration
  • Perform or organize lab equipment maintenance.
  • Assist in preparation of equipment for production
  • Perform routine inventory (e.g., chemicals, supplies, etc.) for lab, and assist in ordering.
  • Assist in maintaining inventory database and SAP inventory
  • Cleaning and sanitation of Laboratory / QC areas.
  • Perform QC Inspections on the Manufacturing floor.
  • Issue a QIR for non-conforming product.
  • Carry out QC testing and examination

Focus for position may include one or more of the following (specific focus will be stated next to the employee name, however this does not exclude performance of all):

·      Training:

  • Perform training to new or changed procedures.
  • Training of new hires (QC Operator I PrA)

·      Documentation:

  • Prepare Certificate of compliance (COC)
  • Perform batch (DHR) and irradiation certificate review.

·      Chemical Solutions:

o   Perform solution inventory planning, and subsequent production and SAP transactions of solutions.

·         Product Evaluation:

o   Test non-conforming product to resolve QIR issues

·      Evaluate customer returned product (technical and   administrative claims)

·      Other duties as assigned

Authority:

 

·   Evaluation of products according to valid QMI documents.

·   Release incoming goods according to valid Certificate of Analysis (e.g., Nipro, BCA, EDTA, Safety Blood Collection Set).

·   Restriction of non-conforming product according to appropriate QMI documents (physical and SAP).

·   Release/scrap ERP transactions of product according to valid QMI documents (following sterilization, following QIR evaluation in cooperation with QM.) .

·   Release of solutions in to Vacuette (testing and SAP).

·   Training of new or existing QC employees regarding QC procedures and use of equipment.

·   Release of daily standard row check.

·   Communication and information exchange with affiliated Greiner facilities.

·   Review and Approval of QC documentation.

Job Requirements:

 

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

·   Must have 3 years of experience as QC Operator I at GBO or equivalent manufacturing facility

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

·   Must have sufficient communication and writing skills.

·   Must pass pre-employment test.

·   Basic computer knowledge and MS office skills.

·   Must have basic GMP and GLP experience

·   Must have experience handling chemicals

·   Must have experience with lab testing equipment and analyzer

·   Must have knowledge with basic statistic and calculations

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.

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.

 

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