Benefits: All Silgan Unicep employees are eligible to participate in our dental, medical and/or vision benefits after a probationary waiting period.
- Consult with subject matter experts to ensure a clear understanding of documentation to be produced, edited, and released for use.
- Compile and analyze source material to be used to approve Quality and operational documents.
- Coordinate editing, composition, and release of controlled documents in accordance with specifications, standards, and other requirements.
- Coordinate Document Control activities to ensure controlled documents are accurate and adequate, including in-process and final reviews.
- Review approved and draft documentation to make recommendations and approved revisions to scope, format, content, and dissemination of controlled documents.
- Coordinate with HR for entry of employee records, updates, and completed trainings into the Quality System.
- Maintain corporate standards for all controlled documents.
- Maintain storage, management and control of all documents and records.
- Administer periodic audits and reviews of controlled 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 document control activities are completed as needed to meet company needs.
- Coordinate with Program Managers on New Product Introductions to ensure that all activities are completed in the order required and in a timely manner.
- Route and track proposed documents for final release.
- Ensure compliance with GMP, GDP, FDA, OSHA, QSR and all other regulatory requirements, in accordance with company policy.
- Adhere to company safety requirements.
- Regular attendance.
- All other duties as assigned.
- Prior experience managing and editing controlled documents.
- High school diploma or equivalent.
- Prior experience in an FDA-regulated manufacturing facility preferred.
- Knowledge of GMP/GDP 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 Outlook, 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.