Metrology Specialist

4 weeks ago


Philadelphia, Pennsylvania, United States IntePros Full time

IntePros is seeking a skilled Metrology Specialist to support the quality management system for laboratory instruments. The ideal candidate will have experience with validation and calibration, as well as a strong understanding of cGMP regulations.

Key Responsibilities:

  • Create electronic instrument equipment validation plans in tracking and approval systems.
  • Develop documentation and revisions to support the quality management system for laboratory instruments.
  • Provide input and support to maintain project schedules and activities for new instrument installation projects.
  • Review and manage instrument repair documents for compliance to work instructions.
  • Support audits, including regulatory, customer, and quality management system audits.
  • Write installation qualification (IQ) documents, operational qualification (OQ), and process qualification (PQ) validation documents for new laboratory instruments.
  • Develop documents such as laboratory investigations, work instructions, and procedures.
  • Provide updates to weekly instrument meetings on the status of documents and activities.
  • Responsible for data input into SAP equipment, calibration, and maintenance module.
  • Develop key validation documents using functional, user requirements, design specifications, equipment manuals, and risk assessments for fully compliant GMP instruments.
  • Support and maintain the instrument quality program, including annual installation qualifications, preventative maintenance documentation, and instrument asset life cycle management.
  • Collaborate with lab employees, onsite contractors, and outside vendors for repair and installation of lab equipment.
  • Stay current with new technologies and cGMP regulations.
  • Support the Lab Metrology group with other activities and projects as needed.
  • Perform follow-up activities for metrology area of work.

Requirements:

  • Bachelor's of Science degree in a related area.
  • 3 years of documentation and validation experience in the pharmaceutical industry.
  • Strong understanding of cGMP regulations and quality management systems.

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