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QC Doc Review Specialist (Temp)

Company: OraSure Technologies
Location: Bethlehem
Posted on: June 21, 2022

Job Description:

SUMMARYIndividual will be responsible for performing quality control document review functions related to ensuring compliance to applicable FDA, ISO, and Canadian Medical Device requirements applied to currently approved products and products under development. ESSENTIAL JOB FUNCTIONS

  • Participate in the preparation and review of documents and procedures supporting compliance to Quality System requirements.
  • Perform nonconformances investigations, risk assessments, CAPA investigations and closures.
  • Review and initiate change control notifications to maintain compliance.
  • Review and approve documentation for in-coming raw materials and quality control documents to ensure compliance with the Quality System requirements, including archiving of quality control records, in accordance with established document retention policies.
  • Maintain a thorough knowledge of appropriate standard operating procedures and work instructions.
  • Participate in evaluating Quality Control functions to ensure continuous improvement of the Quality System.
  • Ability to trend quality control data in excel or any other trending software.
  • Other tasks as assigned.QUALIFICATIONSStrong planning, organizational and time management skills.Able to handle multiple projects simultaneously.Attention to detail, and good problem solving skills.Self-motivated and able to work independently.Well-developed communication skills both written and oral.Flexible, able to work overtime as needed.Ability to organize work to meet deadlines.EDUCATION and/or EXPERIENCEBachelor's degree preferred with minimum 3 yrs experience or HS diploma with minimum 5 years experience, in a health sciences, regulatory, clinical or other related technical field in an FDA regulated industry.Well-developed PC skills, knowledge of Microsoft applications (Office, Excel, Power Point, etc) or equivalent required. PHYSICAL REQUIREMENTSAbility to work at least 40 hours in an office or lab environment Ability to follow written and oral directionsAbility to use office equipment (e.g., PC, fax machine, copy machine)Ability to perform general mobility functions (e.g., sitting, bending, standing, filing, light lifting)OraSure and its subsidiaries is committed to ensuring equal employment opportunities for all. All employment decisions, policies and practices are in accordance with applicable federal, state and local anti-discrimination laws.

Keywords: OraSure Technologies, Bethlehem , QC Doc Review Specialist (Temp), Other , Bethlehem, Pennsylvania

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