Jr Scientific Technical Writer - Lab Operations

at  Thermo Fisher Scientific

SUMMARY:

Assist with preparation of analytical method validation protocols and reports, method transfer protocols and reports, analytical methods, and specifications used by the Development Laboratory ensuring they meet current regulatory, corporate and industry standards. Perform bench work to support client projects.

EDUCATION:

Bachelor of Science (B.Sc.) in Chemistry or related science

EXPERIENCE:

Minimum 3 years’ pharmaceutical laboratory work experience
Experience in preparation of technical documents
Experience in laboratory testing and method validation
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered
Knowledge, Skills, and Abilities:
Strong knowledge of analytical method validation requirements. Excellent Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge. Knowledge of regulatory requirements including USP/NF and Ph. Eur. Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint, Chemstation and OpenLab. Well organized and detail oriented. Excellent interpersonal and communication skills (both oral and written). Ability to work well independently and in a team environment with limited supervision. Ability to prioritize multiple tasks. Proficient 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. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

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 a comprehensive statement of work, 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 align 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.

• Assist with preparation of technical documents such as method validation and transfer protocols, reports, analytical methods, and specifications.
• Help to provide input on generation of method transfer plans for incoming projects.
• Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
• Independently carry out HPLC, dissolution, GC and physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs).
• Work Proficiency with Empower, NuGenesis, MS Word & Excel Software.
• Recognize and report unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conduct laboratory investigations under direction.
• Maintain a safe working environment and report potential hazards.
• Perform alternating or rotating shift work (as required)