Metrology Specialist

4 weeks ago

Philadelphia, Pennsylvania, United States IntePros Full time

IntePros is seeking a highly skilled Metrology Specialist to support the quality management system for laboratory instruments. The ideal candidate will have a strong understanding of cGMP regulations and experience with Quality Management Systems.

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.
  • List any required certifications.

Preferred Knowledge, Skills, and Abilities:

  • Strong understanding of a cGMP environment.
  • Experience with Quality Management Systems and good documentation practices.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.

Travel Requirements:

  • Minimal travel required.

Physical & Mental Requirements:

  • Employee may be required to lift objects (up to 25 lbs) without assistance.
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize.
  • Use written and oral communication skills.
  • Learn and apply new information and new skills.
  • Work under deadlines with constant interruptions.
  • Must maintain the ability to work well with others in a variety of situations.

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