Technical Documentation Control Lead Specialist

Compiles and maintains technical documentation such as blueprints, drawings, change orders and specifications. Examines documents to verify completeness and accuracy of data and resolves discrepancies with document originators. Maintains computerized document control records management system and/or hardcopy documents to ensure compliance with all applicable and required standards, including GMP (good manufacturing practice) and QSR (quality system regulation) requirements. Develops and maintains procedures and standards for maintaining documents and change control of documents, including document development, approval, production, distribution and amendment. Plans and directs document and content management life cycles and may work with either structured or unstructured metadata.

Primary Purpose

Completes specialized document control tasks requiring deep knowledge of systems and standards, ensuring accuracy for high-volume or critical projects. Maintains master records and implements process improvements to enhance efficiency and compliance.

Duties and Responsibilities

Serves as a technical resource for document control standards and compliance requirements.

Advises project teams on best practices for document lifecycle management.

Supports automation initiatives for document workflows and version control.

Maintains global or multi-site document retention and security protocols.

Prepares documentation for high-stakes audits and regulatory inspections.

Generates analytics reports to monitor document performance and compliance trends.

Works with IT teams to ensure repository security and system reliability.

Promotes continuous improvement in document control processes through feedback and testing.

Performs other duties as assigned.

Education

Required: High school diploma or equivalent.

Experience

Required: Typically requires 7 years of related experience.

Knowledge, Skills and Abilities

Required: Technical Documentation - Technical documentation refers to any document that explains the use, functionality, creation, or architecture of a product.

Required: Document Control Management - The systematic management of documents, including their creation, revision, approval, and distribution, to ensure compliance, consistency, and accessibility.

Required: Data Verification - The process of ensuring the accuracy, completeness, and reliability of data through various validation techniques and tools to maintain data integrity and quality.

Required: Regulatory Compliance - Ensuring an organization's adherence to laws, regulations, guidelines and specifications relevant to its business processes.

Required: Engineering Drawing/Blueprint Interpretation - Engineering drawings are a rich and specific outline that shows all the information and requirements needed to manufacture an item or product.

Required: Database Management - The function of managing and maintaining database management systems (DBMS) software.

Required: Version Control Management - A system that records changes to a file or set of files over time so that you can recall specific versions later.

Required: Standards Management - Sets standards correctly and efficiently, and adheres to them.

Required: Documentation and Records Management - Creating, distributing, using, maintaining and disposition of recorded information maintained as evidence of business activities and transactions.

Required: Auditing - The systematic examination, analysis, and evaluation of processes, records, or systems to verify their accuracy, compliance, effectiveness, and integrity, often conducted by independent professionals to provide assurance or identify areas for improvement, which can be applied to areas beyond finance, such as operational, IT, or compliance audits.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled