Scientist II or III
3 days ago
We are seeking a highly skilled Scientist II or III to join our team as a Metrology Specialist. This is a full-time position working as a full-time employee of Parexel FSP on a long-term assignment onsite at one of our clients located in West Point, PA.
This position offers a comprehensive benefits package, including sick time, 401K, paid holidays, and paid time off. However, please note that this position does not offer any sponsorship.
Key Responsibilities- Prepare, review, and approve instrument/equipment documentation, including master equipment lists, qualification documentation, and calibration documentation.
- Coordinate service activities across various vendors and service engineers, 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.
- 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.
- Experience with maintenance of analytical instrumentation, such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution, with the ability to troubleshoot them.
- Experience with computerized standalone systems GMP validation requirements.
- Familiarity with authoring relevant instrument standard operating procedures (SOPs).
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.
We are 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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