Thermo Fisher Scientific
Labs FSP Scientist - GMP, Chemistry
Thermo Fisher Scientific, Boston, Massachusetts, us, 02298
Overview
Join to apply for the Labs FSP Scientist - GMP, Chemistry role at Thermo Fisher Scientific. Responsibilities
Oversee RSL method validations and/or method transfer activities to support project timelines. Serve as RSL representative in cross-functional, cross-departmental working teams Perform data review of method validations to meet project timelines May support in the managing of RSL change controls, deviations, and investigations. Assist in troubleshooting of analytical methods when necessary Authors and reviews SOPs, analytical methods, protocols and reports May support external testing oversight for incoming materials Assists in reference standard qualification/COA generation Participates in compliance related teams working towards the goal of continuous improvement. Education and Experience
Bachelor's degree or Master's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-4 years with bachelors or 0-2 years with masters). Preferred Experience
Previous industry experience with at least 1 year of method validation/transfer experience Knowledge, Skills and Abilities
Solid understanding and knowledge of general chemistry. Strong knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections. Strong knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements. Knowledge of Nuvolo, Veeva, and QDOCS is a plus. Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance. Ability to utilize Microsoft Excel and Word to perform tasks. Proficiency on technical operating systems. Proven problem solving and troubleshooting abilities. Effective oral and written communication skills. Proven ability in technical writing skills. Time management and project management skills. Ability to work in a collaborative work environment with a team. Ability to train junior staff. Working Environment
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access: Job Seekers with a Disability information and accommodation process; contact 1-855-471-2255 for accommodations.
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Join to apply for the Labs FSP Scientist - GMP, Chemistry role at Thermo Fisher Scientific. Responsibilities
Oversee RSL method validations and/or method transfer activities to support project timelines. Serve as RSL representative in cross-functional, cross-departmental working teams Perform data review of method validations to meet project timelines May support in the managing of RSL change controls, deviations, and investigations. Assist in troubleshooting of analytical methods when necessary Authors and reviews SOPs, analytical methods, protocols and reports May support external testing oversight for incoming materials Assists in reference standard qualification/COA generation Participates in compliance related teams working towards the goal of continuous improvement. Education and Experience
Bachelor's degree or Master's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-4 years with bachelors or 0-2 years with masters). Preferred Experience
Previous industry experience with at least 1 year of method validation/transfer experience Knowledge, Skills and Abilities
Solid understanding and knowledge of general chemistry. Strong knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections. Strong knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements. Knowledge of Nuvolo, Veeva, and QDOCS is a plus. Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance. Ability to utilize Microsoft Excel and Word to perform tasks. Proficiency on technical operating systems. Proven problem solving and troubleshooting abilities. Effective oral and written communication skills. Proven ability in technical writing skills. Time management and project management skills. Ability to work in a collaborative work environment with a team. Ability to train junior staff. Working Environment
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access: Job Seekers with a Disability information and accommodation process; contact 1-855-471-2255 for accommodations.
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