Documentation Reviewer II

at  Thermo Fisher Scientific

SUMMARY:

Responsible for independently reviewing various technical reports and raw data generated in Lab
Operations.

EDUCATION:

Bachelor of Science in Chemistry or related science.

EXPERIENCE:

Minimum 3 years of previous pharmaceutical analytical development experience.
Previous document reviewer experience preferred.
Familiar with current ALOCA principles.
Must have Empower software experience
Must be able to work afternoons
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

KNOWLEDGE, SKILLS AND ABILITIES:

Basic understanding the common analytical technologies (e.g., High Performance Liquid Chromatography
(HPLC), Gas Chromatography, Ultraviolet (UV) spectroscoy, titration, and raw material testing. Excellent
written and oral communication skills. Good working knowledge of Good Manufacturing Practices,
International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA)
requirements. Strong organizational skills and detail oriented. Should have GMP chromatography
experience (Specifically EMPOWER is an asset). Direct pharmaceutical experience in a GMP environment.
Ability to meet deadlines and prioritize. Demonstrated computer proficiency with Microsoft Office programs.
Proficiency with the English Language.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office
locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation
(lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including
ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor,
operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and
arms, talk, and hear for prolonged periods of time. Use of Personal Protective equipment may be required
and may include any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety
apron, organic respirator occasionally.

 Review independently all regular technical documents (e.g., batch testing, stability testing and method
validation) and raw data generated in the laboratories with high quality and deliver within agreed
schedule.
 Ensure the test methods, protocols and Standard Operating Procedures (SOPs) have been followed
by the scientists/chemists.
 Verify the integrity and traceability of all data generated and reported.
 Follow up with scientist/chemists/technicians to ensure that all necessary corrections are corrected in
accordance with Good Manufacturing Practices’ standards.
 Notify department supervisor/manager regarding omissions, incomplete testing results or other
irregularities.
 May be required to travel to different sites depending on business requirements (as required)
 Maintain a safe working environment and report potential hazards.
 Perform alternating or rotating shift work (as required)