Job Description

• Associate degree in writing or a technical field with minimum of two (2) years of experience on similar job or Bachelor's Degree in science from an accredited college or university
• Experience working in a Pharmaceutical, Medical Devices or regulated industry
• Able to read and understand technical and regulatory literature
• Knowledgeable in cGMP and FDA regulations
• Planning and organization skills; ability to manage multiple projects in parallel
• Strong attention to detail
• Demonstrated ability to work well in a fast-paced setting
• Excellent written and verbal communication skills, and interpersonal skills
• Experience with or able to quickly learn document management software
• Computer proficiency: Word, Excel and Power Point

• Converts vendor and customer documents (specifications, methods, etc.) into company format
• Creates certificates of analysis (CofAs) and stability reports
• Writes risk assessments including residual solvents and elemental impurities
• Prepares and optimizes templates to improve efficiency and ensure continuity of style and content for documents
• Author and revise technical documentation including batch records, process characterization protocol, stability protocols, quantitative formulas and ingredient lists.
• Verify document details before sending out for electronic approvals
• Utilize technical writing strategies to ensure content of documentation is clear, concise, and complete
• Author and manage change controls as necessary to approve and implement new documents as well as revisions to documentation to facilitate scale-up of new products in manufacturing facility and stability study as per ICH guidance
• Coordinate with R&D, quality, supply chain, labeling, regulatory and manufacturing representatives to ensure all project documentation requirements are achieved
• Draft minor deviations and investigations as required
• Uploads documents in Agile system
• Prepares purchase orders in Oracle
• Tracks overdue documents, and supports document owners on revisions as well as creating the change controls and facilitate their approval
• Obtains necessary approvals for all types of documents
• Writes method transfer, verification and validation protocols and report
• Writes test methods and reviews and updates current test methods as necessary
• Organizes data associated with methods, stability CofAs and reports
• Other duties may be assigned as deemed appropriate by management.

• Employees are required to wear eye protection and lab coats while in the lab
• Complies with all Company policies and procedures, including safety rules and regulations
• Work is performed in a standard office environment
• Subject to standing, walking, bending, reaching, stooping, and lifting of objects up to 25 pounds

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