About this role
Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting Job Description
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