SUMMARY OF POSITION :
This position will provide technical support and document preparation, finalization facilitation and management.
ESSENTIAL FUNCTIONS :
1 . Provide support and prepare documents for use in cGMP compliant facility.
2. Facilitate document flow through the authoring, preparation, downstream functions/processes necessary for document finalization.
3. Ensure final documents meets company standards and cGMP.
4. Compile and publish complex documents as directed
5. QC vendor documents
6. Manage controlled documents
7. Manage inventory control and records.
Possess an in-depth expertise in desktop applications including Microsoft Office and PDF, document management and publishing systems including effective troubleshooting and training skills
Must be detail oriented.
Ability to set and manage multiple priorities and projects to complete tasks within established timeline
Able to work with multiple groups of people at one time.
Must work well under tight and conflicting deadlines.
Strong analytical and problem solving skills.
Must be able to prioritize own work effectively.
Strong interpersonal skills, including ability to remain calm, professional, diplomatic, and positive.
Flexibility to accept new duties as assigned
Education required/ preferred:
Associate’s or bacholer degree in a scientific or related field from an accredited college or university preferred. Experience in cGMP facility, document control, drug development, QA or regulatory preferred.
Organizational Relationship :
This position will report to the Director, Regulatory Affairs and Compliance and will interface with various departments and colleagues at different levels throughout the company.