- Title: Quality Control Chemist
- Code: RCI-17768
- Location: Andover Massachusetts (MA) 01810
- Posted Date: 02/14/2020
- Duration: 18 Months
This role will provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for implementation of analytical assays on new instrumentation. This scope includes QC Instruments (both portable and computer-controlled).
• Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short term/completed remediations
• Performing supporting remediation work in the form of SOP revisions as well as authoring and executing change controls and validation test plans/protocols when required per remediation plans
• Develop, drive and perform comparability studies for implementation of analytical assays on new instrumentation.
Successful candidate requires:
• Strong working knowledge of the validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures.
• Working knowledge of data integrity regulations, guidance, and principles
• Working knowledge of CAPA and change control processes
• Strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QC, QA Validation, Instrument Validation, and IS/IT functions.
• Knowledge and experience with a wide variety of analytical techniques including HPLC, UV/VIS, CGE, FT-IR and ICE.
• A BS degree in science, engineering, computer science, or related technical discipline with minimum 2-3 years pharmaceutical/biopharmaceutical experience in a relevant GMP role (validation, quality control, quality assurance, IS/IT compliance, etc.)
• Past experience working with QC instrumentation in the biopharmaceutical field is preferred but not required.
Position Comments visible to MSP and Supplier: At least 2 years experience working in a GMP environment outside of an academic setting. Please review full JD, skills and education requirements and ensure it is noted on Appendix B and demonstrated on resume.