Technical Writer Ii
Job Description
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.)
Summary:
Prepares 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. In addition to document preparation, provides training to other Scientific Technical Writers.
Essential Functions:
- Prepares technical documents such as method validation and transfer protocols, reports, analytical methods, and specifications
- Performs analytical assessments of compendial updates to identify required laboratory activities
- Generates method transfer plans for incoming projects
- Attends client meetings related to technical document requirements
- Provides training and technical expertise to other Scientific Writers
- May be essential to perform alternating or rotating shift work (as required)
Education:
Bachelor of Science (B.Sc.) in Chemistry or related science.
Experience:
Minimum 3 years previous pharmaceutical laboratory work experience and strong knowledge of analytical method validation requirements.
Experience in laboratory testing and method validation
Experience in preparation of technical Documents
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
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.
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Job Detail
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Job IdJD2363972
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMississauga, ON, Canada
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EducationNot mentioned