The Corporate Quality Systems Document Control Manager will support and implement quality systems associated with Document Management with a focus on document processing and process enhancement for both Product Quest Manufacturing LLC (FL) and Ei LLC (NC). The Corporate Quality Systems Document Control Manager will work closely with SMEs to execute workflows and business processes that align with best practices. The position reports to the VP of Quality. Responsibilities
Responsible for the management of all documentation and archival processes to support corporate functions.
Collaborates with cross-functional departments, and manufacturing sites to ensure timely implementation of document change requests.
Write and initiate changes to controlled documents (e.g., SOPs, manuals, forms, and training material) for document and records management processes.
Serve as EDMS administrator and primary processor, assist & troubleshoot customer issues
Maintain a document management process compliant with regulatory, quality, and company requirements.
Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system.
Ensures accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems.
Issues effective documents such as, but not limited to procedures, test methods, specifications validations, and study reports.
Executes strategic initiatives to improve the document management system.
Investigates deviations against the document management system and develops effective corrective action plans.
Develops training content for document management processes and procedures.
Provides training to new staff on document management processes and procedures.
Support audits (internal, external) related to corporate document control management in order to verify that regulatory and quality requirements have been met.
Update and create training curriculum revisions as needed.
Interact with functional departments to establish priorities and deadlines for documentation and records.
Assist users with research questions and with using the document management tool.
Record, publish and notify as to the availability and update of all corporate documentation
Perform other duties as required.
Bachelor’s Degree or Minimum 7 years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems.
Strong knowledge of GMP, SOPs and quality system processes (manual and electronic).
Excellent organizational skills and ability to review processes or procedures.
Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (such as Document Locator, documentum, Veeva or equivalent).
Strong written and verbal communication skills.
Ability to communicate and work independently with scientific/technical personnel at all levels.
Experience in pharmaceutical field.
Quality systems demonstrated working knowledge in areas such as change control, document change control audits.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).