Parexel
Scientist II or III - Analytical Chemist Metrology Specialist
Parexel, Phila, Pennsylvania, United States
Overview
Parexel FSP is seeking a Scientist II or III – Analytical Chemist Metrology Specialist. This is a full-time position, onsite at a client site in West Point, PA, working as a Parexel FSP employee on a long-term assignment. The role offers full benefits, sick time, 401K, paid holidays, and paid time off. The position does not offer sponsorship. The Analytical Chemist Metrology Specialist is responsible for the oversight of regulated and non-regulated laboratory equipment, including the lifecycle of lab instrumentation from acquisition and installation through routine maintenance, computer system validation, and retirement of regulated systems. Location: West Point, PA. Employment type: Full-time. 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. Qualifications
B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline. 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, Parexel is trusted by life sciences companies to meet long-term staffing needs for scientists and engineers in discovery and development, 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. Application notes
Come join us!
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Parexel FSP is seeking a Scientist II or III – Analytical Chemist Metrology Specialist. This is a full-time position, onsite at a client site in West Point, PA, working as a Parexel FSP employee on a long-term assignment. The role offers full benefits, sick time, 401K, paid holidays, and paid time off. The position does not offer sponsorship. The Analytical Chemist Metrology Specialist is responsible for the oversight of regulated and non-regulated laboratory equipment, including the lifecycle of lab instrumentation from acquisition and installation through routine maintenance, computer system validation, and retirement of regulated systems. Location: West Point, PA. Employment type: Full-time. 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. Qualifications
B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline. 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, Parexel is trusted by life sciences companies to meet long-term staffing needs for scientists and engineers in discovery and development, 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. Application notes
Come join us!
#J-18808-Ljbffr