Lead QA Technician

Thermo Fisher Scientific

  • Bleiswijk, Zuid-Holland
  • Vast
  • Voltijds
  • 22 dagen geleden
Work Schedule OtherEnvironmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, WarehouseJob DescriptionJob DescriptionPosition Summary:Join Thermo Fisher Scientific Inc. as a Lead QA Technician. Working a rotating 7 day a week shift pattern, you will be responsible for support quality systems, regulations, and the Quality Manager.Key Responsibilities:
  • Manage SOPs, including Document Control as Coordinator on eDMS.
  • Review and approve Trackwise QRs including CAPAs, deviations and complaints
  • Draft & approve operational documentation.
  • Perform quality reviews of change controls and status control of products/materials.
  • Manage items and content on SFLMS and conduct supplier assessments.
  • Ensure compliance with our QMS and applicable regulations/standards.
  • Assure adherence to EU GMP and IGJ regulations to maintain site licenses.
  • Perform duties as an approved Archivist, verifying quality tasks.
  • Support client audits and internal audit programs as needed.
  • Provide training and proficiency assessments.
  • Check operational documentation for ALCOA+ and Good Documentation Practices.
  • Perform QA related tasks assigned by the site Head of Quality.
  • Support QC incoming inspection and disposition activities.
  • Perform Quality Control related tasks as required.
  • Travel as the need arises and perform off-site work when vital.
Minimum Requirements/Qualifications:
  • Degree or equivalent experience in relevant subjects or at least 1 year of GMP experience.
  • High degree of accuracy and attention to detail.
  • Ability to interpret general procedures and regulations.
  • Strong problem-solving skills and the ability to present information effectively.
  • Proficient in MS Office and capable of mastering clinical trial database systems.
  • Excellent verbal and written communication skills.
  • Proven teamwork skills and the ability to operate under pressure.
  • Employment is subject to a 10-year history screening for criminal records, qualifications, previous employment, and credit history.
  • Proficient in English.
Although not required, the following would be preferable:
  • Live no more than 30 minutes driving time from the facility.

Thermo Fisher Scientific