R D/Mfg Scientist II-Reviewer Thermo Fisher Scientific - 3.4 Greenville, NC Job Details Full-time 18 hours ago Qualifications Data integrity assurance Stability testing Immunological assays Document review (document control) Empower (software) Laboratory safety Investigations regulatory compliance Safety protocol adherence Stability studies in drug product development Team leadership Immunological laboratory techniques Pharmaceutical regulatory compliance Safety regulations High-performance liquid chromatographs Laboratory information management systems Corrective and preventive actions (CAPA) English Mid-level Technical report writing 3 years Data integrity and documentation ICH guidelines Laboratory reports Titration Task prioritization Pharmaceutical company experience Scientific protocols Team training Pharmaceutical analysis Laboratory standard operating procedures Full Job Description 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