Reporting to the Quality Assurance Manager, the Document Control Specialist is responsible for oversight activities specific to documentation control, and is focused on maintenance and processing of document workflows for the facility, including document management system, batch and process documentation (issuance and control), and document storage (physical and electronic).
Manage the document lifecycle including preparation, routing, review, approval, distribution, and archival.
Review documents submitted to ensure the correct use of templates, correctly entered data, and document types.
Maintain documentation and records including audit reports, SOPs, regulatory documents, batch records, etc.
Create and manage approval workflow for final procedures, documents, records, specifications, etc.
Maintain audit training records to ensure records are complete and accurate before filing.
Perform advanced word processing.
Publish weekly reports and logs identifying open workflows, submittals, and other documents.
Assist in developing document control related procedures and implementation.
Organize and ensure accurate and reliable filing systems for all paper-based GMP documents.
Work with team members to ensure proper maintenance and retention of all qualifying documents and information.
Ensure that document retention and review systems are compliant with internal and external standards, including ISO 22716 and FDA.
Maintain flexibility to provide additional support as requested or required based on individual production and manufacturing needs.
Provide support in external and internal audits.
Prepare finished goods COAs, Fill Sheets and Spec Sheets for new products.
Assemble batch kits for production.
Perform the issuing and reviewing of change management documentation.
Perform other duties as assigned.
Bachelors degree in Library Science, Communications, or Business Administration preferred.
Minimum of 3 years of technical writing/document control experience in the personal care/cosmetics/contract manufacturing industry.
Fast, efficient, high-level user of Google Suite tools.
Innovative, open-minded, collaborative, and team-oriented attitude.
Experience with Electronic Document Management systems, Microsoft Office Suite, and Adobe Acrobat.
Experience with maintaining and reporting for a Quality Management System (QMS).
Detail oriented with exceptional organizational, time management and interpersonal skills.
Team player with the ability to work across multiple functions, cultures, and disciplines.
Positive and constructive attitude.
Demonstrated problem-solving ability in a cross-functional environment.
GMP / ISO 22716 experience a plus.
Ability to sit and/or stand for extended periods of time.
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