Analytical Chemist Metrology Specialist

3 weeks ago

North East, Pennsylvania, United States PAREXEL Full time

We are seeking a highly skilled Regulated Laboratory Equipment Specialist to join our team at Parexel FSP. This full-time position offers a range of benefits, including full benefits, sick time, 401K, paid holidays, and paid time off. The successful candidate will be responsible for the oversight of regulated and non-regulated laboratory equipment, including the lifecycle of lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement.

Key Responsibilities:

  • Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation.
  • Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships.
  • Gain a working knowledge of laboratory equipment to facilitate troubleshooting and/or perform maintenance or calibration activities.
  • Participate in computer system validation activities associated with new or upgraded equipment or software packages.
  • Support the purchase, installation, and equipment qualification of new laboratory equipment.
  • Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training, and cross-site support.
  • Originate and progress Notice of Event (NOE) and Change Management (CM) records.
  • Perform and document investigations and assist in developing/implementing CAPA plans.
  • Represent the laboratory on all aspects of laboratory equipment during audits.
  • Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures.

Requirements:

  • Experience working within a regulated (GMP) laboratory.
  • Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems.
  • Familiarity with standalone computer system validation requirements.
  • Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system-related schedules, documents, and maintenance tasks.
  • Capable of working independently under moderate supervision.
  • Strong verbal and written communication skills.
  • Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators.

About Parexel:

Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

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