- Write technical documents for business processes, procedures, and training.
- Consult with subject matter experts to ensure a clear understanding of documentation to be produced
- Compile and analyze source material to be used to create technical documents.
- Coordinate editing, composition, production, and delivery in accordance with specifications, standards, and other requirements.
- Recommend use of layouts, graphics, drawings, tables, exhibits, illustrations, and charts to clarify objectives.
- Coordinate Quality Control activities to ensure technical documents are accurate and adequate, including in-process and final reviews.
- Review existing documents and make recommendations and revisions to scope, format, testing, methods of production, and dissemination.
- Maintain corporate standards for all technical documents.
- Perform periodic audits and reviews of technical documents to determine if updates and/or changes are required.
- Maintain change control procedure in compliance with regulatory guidelines and company policy.
- Coordinate the routing of change controls for pre- and post-approval.
- Coordinate with responsible parties to ensure that activities are completed as needed, or coordinate with Program Manager on New Product Introductions to ensure that all activities are completed in the order required and in a timely manner.
- Create and release production documentation packages.
- Route and track proposed documents for final release.
- Ensure compliance with GMP, FDA, OSHA, QSR and all other regulatory requirements, in accordance with company policy.
- Adhere to company safety requirements.
- Regular attendance.
- Other duties as assigned.
- Knowledge of engineering practices to develop technical documentation.
- Prior experience writing technical documents.
- High school diploma or equivalent.
- Prior experience in a FDA-regulated manufacturing facility preferred.
- Knowledge of GMP requirements preferred.
- Experience formatting documents to comply with established guidelines.
- Ability to follow written and oral instruction.
- Strong organizational skills.
- Strong interpersonal skills to communicate effectively at all levels within the organization.
- Proven ability to meet established timelines.
- Ability to work both independently and as a member of a team.
- Good attention to detail.
- Proficient with Microsoft Office products, including Word and Excel.
- Frequently required to sit, talk, and hear.
- Frequently required to stand and walk.
- Regularly required to lift and/or move up to 20 pounds.
- Vision ability including close vision, distance vision, color vision and the ability to adjust focus.
Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.