Scientist II or III - Analytical Chemist Metrology Specialist - FSP

Parexel

2d•Onsite

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Scientist 2 or 3 - Analytical Chemist Metrology Specialist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. The Analytical Chemist Metrology Specialist is responsible for the oversight of regulated and non-regulated laboratory equipment. This role 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 Qualifications – B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline Scientist 2 - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience Scientist 3 - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience 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 Required Skills and Experience 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 Desired Skills and Experience Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them. Experience with computerized standalone systems GMP validation requirements Familiarity with authoring relevant instrument standard operating procedures (SOPs) 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. Come join us! #LI-DK1 EEO Disclaimer Parexel 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. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

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

Nice To Haves

Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them.
Experience with computerized standalone systems GMP validation requirements
Familiarity with authoring relevant instrument standard operating procedures (SOPs)

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