CMC Metrology Specialist Scientist II - FSP

Parexel International Corporation

Quakertown, Pennsylvania

Onsite in West Point, PA

B.S. Degree in Chemistry, Biochemistry, or closely related sciences

Metrology specialist responsible for the oversight of regulated and non-regulated laboratory equipment Will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement

Position 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 with 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

QualificationsRequired Experience and Skills: Experience working within a regulated (GMP) laboratory Experience maintaining 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 EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

2021-05-09 00:05:17

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