Document Specialist Jobs

About The Position

Requirements

• BS/BA degree with minimum of 8-10 years of experience in a quality discipline, with a minimum of 5 years within Document Control in the pharmaceutical, medical device, or biological industries.
• Experience with electronic Quality Management Systems (eQMS) or document management platforms such as TrackWise Digital, Veeva, MasterControl, or similar systems.
• Experience with global or multi-site document control programs.
• Experience supporting harmonization or transformation of document control processes in a growing or complex organization.
• Demonstrated experience administering GxP controlled documentation within an eDMS.
• Strong knowledge of document control principles, quality systems, and controlled documentation practices in regulated environments.
• Knowledge of retention and archival requirements for GxP records.
• Experienced with supporting pharmaceutical and/or medical device GMP compliance regulatory inspections.
• Proficient in technical writing skills.
• Expertise in MS office suite programs.

Nice To Haves

• Good planning and project management skills.
• Good verbal, written and presentation skills at all levels both internally and externally.
• Ability to communicate effectively at a variety of levels of the organization, as well as coach and mentor members of GxP functions on compliance requirements and topics.
• Must be detail oriented with the ability to multitask and respond to ever changing priorities.
• Strong attention to detail with the ability to ensure accuracy, completeness, and consistency of controlled documentation.
• Ability to work independently and drive on time completion of responsibilities and assigned tasks.

Responsibilities

• Administer and maintain the corporate document control process in alignment with applicable internal procedures and regulatory requirements.
• Responsibility for global governance and oversight of document control lifecycle and process, hierarchy and document templates & formatting.
• Act as the SME to support site Doc Control Admins.
• Serve as a subject matter resource for the eDMS (Trackwise Digital) used to manage controlled documents and associated workflows.
• Provide project and validation support for activities involving modifications, upgrades, and business process changes related to the electronic Document Management System.
• Coordinate the creation, review, approval, issuance, revision, and obsolescence of controlled quality documents.
• Support initiatives such as eForms implementation, document migration, and paper-to-electronic transitions.
• Ensure controlled documents are properly formatted, assigned document numbers, versioned, and routed through the approved workflow process.
• Verify that document changes are reviewed and approved by appropriate functional stakeholders prior to implementation.
• Maintain official document revisions and ensure archived versions are retained in accordance with record retention requirements.
• Support implementation and ongoing administration of document hierarchy structures across corporate and site quality systems, as applicable.
• Ensure document control practices comply with applicable regulatory expectations and company procedures for GxP documentation and record management.
• Provide guidance and training to document authors, reviewers, approvers, and functional stakeholders on document control requirements and processes.
• Support onboarding and refresher training related to document management procedures and eDMS usage.
• Support internal audits, external audits, customer audits, and regulatory inspections by providing requested controlled documents, document history, and evidence of document control compliance.
• Troubleshoot document workflow issues and coordinate with system administrators, IT, or business process owners as needed.
• Provide front / back room support for inspections and audits.
• Assist in the preparation of document control metrics, reports, and summaries for Quality Management Review and other governance forums.
• Identify and escalate documentation compliance risks, overdue periodic reviews, workflow bottlenecks, or procedural nonconformances.
• Support remediation activities related to document control observations, deviations, investigations, CAPAs, or audit commitments.

Benefits

• comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
• life and disability benefits
• pre-tax accounts
• a 401(k) with company contribution
• a variety of other benefits
• generous time off package including paid vacation, holidays, sick days, and paid parental leave