Argen Corporation currently has an exciting opportunity for a Document Control Specialist to join a growing, technology-focused and service-oriented team. If you thrive in a fast-paced and dynamic environment and want to be a part of an organization with an unwavering commitment to quality dental solutions, then explore our career opportunities and get to know Argen.
Argen is a family-owned and privately held company based in San Diego, CA with a state-of-the-art manufacturing center that provides high-quality dental solutions to dental labs of all sizes. Founded as a precious metals company in South Africa, Argen has evolved into a dynamic, technology-based manufacturing organization focused on three key business segments, including dental alloys, zirconia, and digital dentistry solutions. Argen continues to invest in innovative research and development, continually improving our current products and developing new solutions for the dental industry. Argen provides our global customers with affordable, high-performance products and industry-leading customer service. Argen's products are FDA-regulated and ISO certified.
About the Opportunity
As the Document Control Specialist, you will manage 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.
In this role, the successful candidate will:
• Manages document processes and systems to ensure custody control and availability of documentation to site personnel, and 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, updates procedures, and creates 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 record 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.
• Other duties as assigned.
What does it take to be a qualified candidate?
• 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!
Working for a growing innovative company like Argen means exciting opportunities for training and learning, career development and advancement from only the best in the dental industry. With all that hard work, Argen is committed to ensuring the welfare of its employees and provides an amazing benefits package that includes:
• Medical, dental and vision Plans
• 401k with Employer Match
• Paid Vacation, Holidays and Sick Time
• Employee Events
• Wellness Programs
• Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more!
EOE/M/F/Vet/Disabled VEVRAA Federal Contractor
- Business Process Improvement
- Certified Global Meeting Planner
- Document Retrieval
- External Audits
- Iso 13485
- Regulatory Compliance