Jr Scientific Technical Writer - Lab Operations
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
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.
Essential Functions:
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)
REQUIRED QUALIFICATIONS
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.
Standards and Expectations:
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators (KPI's) and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.
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.