Scientist II or III - Analytical Chemist Metrology Specialist - FSP

• 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

• B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline
• Scientist II - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience
• Scientist III - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant 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

• 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)

full benefits, sick time, 401K, paid holidays, and paid time off