Document Control Specialist

The Document Control Specialist Manages company documents while also ensuring their accuracy, quality and integrity. Administers the document life-cycle (author, approve, publish, revise, retire, archive) for companywide documents, including SOP's, Work Instructions, and forms. Supports and assists in defining standards and workflows for document management in collaboration with corporate records management.

Schedule: M-F, 7:00 AM - 3:30 PM

Location: 5855 Oberlin Dr. San Diego, CA 92121

The day-to-day:

• Manages document processes and systems to ensure custody control and availability of documentation to site personnel, regional and corporate resources.
• Administers the collection, authorizing, publication, storage and retrieval of documents in Vivaldi.
• Administers the document life cycle (author, approve, publish, revise, retire, archive) for engineering and operational documents, including drawings, correspondence, procedures, and forms.
• Ownership, power user and team lead for the management of the Vivaldi system.
• Scans documents, update procedures, and create documents as required, electronic document templates.
• Assists in the development/review and upkeep of project work plans.
• Solicits, identifies and seeks buy-in for process improvement and data governance opportunities.
• Supports, and implements records management and data governance standardization per regional and corporate operations compliance requirements.
• Serves as the regional resource for corporate and regional records management and data governance.
• Participates in pre-audit support and provide data and records as required to support internal and external audits.
• Assists with the development of document flow procedures.
• Manages document processes and systems to ensure control and availability of documentation to site personnel.
• Provides guidance on document control processes, procedures and training for personnel on an as needed basis.
• Performs and/or support regular audits of document control processes and procedures.
• Trains employees on Document management systems.
• Performs periodic audits of documents and records to ensure accuracy.
• Reviews approved documents for accurate format, signatures, dating and good documentation practices.

What does it take to be successful:

• High School diploma or equivalent
• 1-3 years of document control experience
• 1 plus years of experience within an FDA regulated industry preferred.
• Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.

Our Awesome Benefits!

• Medical, dental and vision Plans
• 401k with Employer Match
• PTO
• Employee Events
• Wellness Programs
• Discounts for home, travel, entertainment and relaxation!

About Us

At Argen, we're in the business of creating healthy, confident smiles one case at a time. We are 500 team members strong. Founded more than 50 years ago as a precious metals company in South Africa, Argen has grown to become the largest dental zirconia manufacturer in North America, largest dental alloy provider worldwide, and leader in digital dentistry solutions with diverse product offerings. Our 140,000 square foot manufacturing center houses more than 150 3D printing and milling machines and operates six days a week. Argen embodies a culture of innovation, continuous improvement, and LEAN practices in support of our mission to help our dental laboratory customers succeed.