Associate Scientist II under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians / assistants. Comply with divisional and site Environmental Health and Safety requirements.
II. Essential Functions
• Labeling, organizing and tracking the flow of documents, including spreadsheets, reports, protocols etc.
• Authors documents, such as stability protocols, text reports, certificates of analysis, and operating procedures
• Performs parallel review of documentation and may become qualified to perform technical review of documents for accuracy, thoroughness and regulatory compliance.
• Develop and execute stability work plans/schedules independently, using customer milestones and Division/site performance standards and metrics.
• Review technical documents for accuracy, thoroughness and regulatory compliance
• Identifies opportunities for improvement projects.
• Perform activities under cGMP as appropriate.
• All other duties as assigned.
III. Position Requirements
Education and Experience:
• Bachelor’s Degree in Life Sciences or Physical Science field. No work experience required
Knowledge/Skills Requirements:
• High Proficiency in Microsoft Office, Word, Excel, Outlook
• Maintain high quality documentation in accordance with applicable regulatory guidance and Site SOPs.
• Ability to learn and retain technical information.
• Proactively address work issues at both an individual level and a team level.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Mathematical and scientific reasoning ability.
• Excellent written and verbal communications skills with internal and external customers.
• Lead by example according to company values and culture.
• Strategy is focused on personal time management and efficiency.
• Well organized with ability to multitask.
• Ability to work effectively under pressure to meet deadlines.
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