Quality Control Manager - PreAnalytics

Job Title:

QC Manager Preanalytics

Responsibility:

·   Organization of Quality control checks on manufacturing floor for Preanlaytics in cooperation with the QA/QC Manager and corporate organization.

·   Lead and supervise QC and laboratory employees for  Preanalytics.

·   Responsible for maintenance of Quality Irregularity Reports (QIRs) file and for periodic reporting in regards to QIRs for Preanalytics.

·   Responsible for using statistical methods to perform trend analysis reports on product nonconformances.

·   Maintenance of Hold area physically and electronically in SAP system.

·   Perform periodic inventory in SAP system.

·   Perform initial training and retraining for laboratory and QC employees in Preanalytics.

·   Organization preparation of chemical solution for manufacturing for Preanalytics

·   Organization of Incoming Good Inspection (IGI) according to valid procedures.

·   Responsible for document exchange in QC Preanalytics.

·   Maintain QM documents for QC Preanalytics in cooperation with the QA/QC Manager.

·   Periodic information exchange and evaluation of Quality trends with GBO-AUT

·   Establish training plans, qualifications and training of subordinate employees.

·   Support budget and financial goals within Quality Department

·   Other duties  as assigned.

Authority:

 

·   Product evaluation according to valid Specifications and Tolerance Plan (STPs) or testing Procedures

·   Final Release of testing procedure for laboratory and Quality control for Preanalytics in cooperation with the QA/QC Manager.

·   Personnel selection for the laboratory and QC Preanalytics in arrangement with the QA/QC Manager.

·   Communication and exchange of results and procedures with counterparts of corporate organization to drive corrections and improvements.

·   Designate employees for closing QIRs after checks for possible corrections and cost evaluations in cooperation with the QA/QC Manager.

·   Decision for restriction or release of product according to valid procedures and standards.

·   Release of QM Documents for Preanalytics

                                                                  

Job Requirements:

 

·   Minimum Bachelor’s Degree in STEM or relevant field and/or appropriate work experience in relevant field

·   Must have 10 or more years of experience in Medical Device, Pharmaceutical, and/or regulated industry.

·   Must have at least 5 or more years of experience in QC laboratory environment

·   Must have at least 5 or more years supervisory experience in a manufacturing lab environment

·   Must have strong verbal and written communication skills

·   Must have strong mathematical and science calculation skills.

·   Strong knowledge of statistical methods and experience with statistical software.

·   Must have passed pre-employment examination, qualification test.

·   Selection of suppliers for laboratory supplies

·   Cooperation with external laboratories for product tests

·   Solid Computer knowledge-Microsoft Office

Physical Requirements:

 
     
  • Must be able to sit, stand and walk for up to 8 hours.
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  • Must be able to lift up to 25 lbs.
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  • Must have appropriate vision to perform detailed quality inspections as outlined in SOPs and TPs.
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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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