Document Control and Records Specialist

Position Summary

The Document Control & Records Specialist supports the Quality Systems function by administering document control, records management, and change control activities within the Quality Management
System (QMS). This position ensures the integrity, accuracy, accessibility, and compliance of controlled documents and records while supporting cross-functional teams in the timely execution of change management processes and regulatory requirements.

Principal Responsibilities

• Administer document control activities within the Quality Management System (QMS), including document creation, review, approval, issuance, revision, archival, retention, and obsolescence.
• Process and track document change requests, engineering change orders (ECOs), and other controlled quality system records through completion.
• Execute document and change management processes within Agile, Legacy Agile, and other applicable systems.
• Maintain controlled documentation and records in accordance with FDA regulations, ISO 13485 requirements, company policies, and Good Documentation Practices (GDP).
• Ensure the accuracy, integrity, organization, and accessibility of quality records and documentation.
• Perform accurate data entry and maintenance of document control databases and record repositories.
• Coordinate document distribution activities and ensure timely communication of document releases, revisions, and obsolescence notifications.
• Collaborate with cross-functional teams to support the timely review, approval, and implementation of document and process changes.
• Support internal, customer, and regulatory audits by providing documentation and records as requested.
• Assist with records retention and archival activities in accordance with company procedures and regulatory requirements.
• Provide backup support for training administration activities, including training record maintenance and documentation.
• Maintain effective working relationships and communicate professionally with employees at all levels of the organization.
• Comply with all applicable FDA regulations, quality system requirements, company policies, operating procedures, and safety requirements.
• Perform other duties and responsibilities as assigned.

Education / Experience Requirements

• Minimum of 2 years of experience in document control, records management, quality systems administration, training administration, or a similar regulated environment.
• Experience working within FDA-regulated, medical device, pharmaceutical, biotechnology, or other highly regulated industries preferred.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Demonstrated attention to detail, accuracy, and organizational skills.

Specialized Skills / Other Requirements

• Working knowledge of document control and records management principles.
• Experience with electronic document management systems (eDMS) and quality systems software preferred.
• Working knowledge of Agile PLM, SAP, and Veeva Vault strongly preferred.
• Familiarity with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and Good Documentation Practices (GDP) preferred.
• Strong verbal, written, and interpersonal communication skills.
• Ability to prioritize multiple tasks and manage competing deadlines in a fast-paced environment.
• Strong problem-solving and organizational skills with exceptional attention to detail.
• Ability to work independently while effectively collaborating within a team environment.
• Demonstrated proficiency in maintaining confidentiality and handling controlled information.

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Working Conditions / Physical Demands

The pay range for this position at commencement of employment is expected to be between ($46,700-$65,400)  however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.