Document Reviewer II

Thermo Fisher Scientific - Greenville, NC (30+ days ago)3.6

Full-time

Job Description
Document Reviewer 2

Summary:
Responsible for independently reviewing all technical reports and raw data generated in Pharmaceutical Development Services (PDS) –Analytical Development (AD) and assists in preparing summaries of data for submission. Generating ideas and recommendations for system improvement and assistance for scientific writing.

Essential Functions:
Reviews independently all technical documents including regular technical documents (e.g., batch testing, stability testing and method validation) and special reports (e.g., pre-formulation report and special investigation reports) and associated raw data generated in the PDS - AD with high quality and deliver within agreed schedule.
Ensures the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the chemists.
Verifies the integrity and traceability of all data generated and reported.
Follows up with chemists to ensure that all necessary corrections are completed in accordance with Good Manufacturing Practices standard.
Notifies supervisor/manager regarding omissions, incomplete testing results or other irregularities.
Trains other reviewers in good documentation practices and the compliance of current quality standard.
May be required to travel to different sites depending on business requirements (as required)
May be essential to perform alternating or rotating shift work (as required)
Other duties as assigned

Education and Experience:
B.Sc. in chemistry or related science in a science related to Pharmaceutical Analysis and at least 5 years of pharmaceutical analytical development experience could also be considered under some circumstances or M.Sc. in a science related to Pharmaceutical Analysis and at least 2 years of pharmaceutical analytical development experience.

Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:
Basic understanding the common analytical technologies (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography, Dissolution, Infrared (IR), Ultraviolet (UV), Differential Scanning Calorimetry (DSC) and Thermal Gravimetric Analysis (TGA).
Excellent working knowledge of Good Manufacturing Practices, International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA) requirements.
Demonstrated computer proficiency with Microsoft Office programs.
Ability to meet deadlines and prioritize
Strong attention to detail.
Excellent written and oral communication skills
Proficiency with the English Language.

Qualifications:
  • Undergraduate degree in Science (preferred)
  • 2+ years of GMP lab experience (required)
  • Previous Peer Review experience (required)
  • Strong communication / collaboration and PC skills (required)
Physical Requirements:
There is little physical effort and fatigue. Walks, stands, lifts small objects and tools, and/or operates keyboard equipment for short duration (eg. lifts very light items such as a stapler). Regular need to attend to and decipher sensory input that requires diligence and attention to interpret effectively. This is typically because data is technical, legal or financial in nature. (e.g., troubleshooting systems software and hardware problems, analysis of budget statements). Located in a comfortable indoor area. Any unpleasant conditions would be infrequent and of short duration.

Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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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.