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Job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Laboratory Setting
The R&D Scientist II-Reviewer independently performs complex data reviews in support of validations, development testing, protocols and reports. In addition, the reviewer is to provide necessary support of in-process, release and stability testing. The reviewer functions are also dedicated to laboratory Integrity Compliance activities as mandated by corporate standards.
Key Responsibilities
Perform cGMP analytical data review for various techniques to ensure adherence to established procedures, analytical standards, GVLs and SOPs
Determine if reported data meets specification or expected standards
Verify that data is correctly entered into its designated software systems for approval (LIMS/SLIM)
Trend data where applicable to ensure requirements are met
Ensure that all laboratory testing and activities are carried out in compliance with regulations, ICH guidelines, and USP/EP Pharmacopeia, GMP and data integrity requirements
Assist in trainings as an SME
Communicate with Project Lead/Managment concerning project status and/or concerns
Demonstrate ability to work as a team player and in a fast-paced environment
Must be able to set project priorities and time management in order to maximize productivity
Actively participate in ongoing trainings and seek out opportunities to increase contributions for development of skills and responsibilities
Work closely with analyst to complete corrections
Might Author and/or review: OOS investigations, Deviations and Change Controls, CAPA, technical reports, Protocols and validation summaries , SOPs
Ensure all job-related safety training and compliance requirements are met
Qualifications
Associates degree required -bachelor’s degree preferred) All degrees must be from a scientific discipline or
Associates degree with 5 years of pharmaceutical experience and 3 or more years of reviewing data for cGMP compliance or
Bachelor’s degree with 3-5 years of pharmaceutical experience and 2 or more years of reviewing data for cGMP compliance
Advanced knowledge and experience in Empower
Advanced knowledge in HPLC, UV, FT-IR, UV, Karl Fischer Titration, IEF (Preferred), ELISA (Preferred), CGE (Preferred), Dot-Blot (Preferred)
Demonstrate knowledge in method validation
Experience with analytical method development, validation, transfer, and verification for drug products and raw materials is advantageous
Experience testing for assay, impurities, content uniformity, potency
Data trending and interpretation of analytical results
Strong knowledge of GMP, GLP regulatory requirements
Strong organizational, communication, and leadership skills
Ability to manage multiple priorities and meet deadlines
Proficiency in Microsoft Office applications
Demonstrated ability to work independently and collaboratively
Fluent in English
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.