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