Document Control Specialist

The Mentholatum Company • Orchard Park, NY

7d

About The Position

This position manages, organizes, and secures quality and regulatory documents to ensure compliance with Current Good Manufacturing Practices (cGMP) at The Mentholatum Company. Duties include creating, reviewing, publishing, and archiving electronic and paper cGMP documents, and administering the Singlepoint document management system and other quality-related software used for consumer complaints and data collection. The role manages user access and system changes through change control, troubleshoots user problems, supports software qualification and validation, and assists with identifying, developing, and qualifying new Singlepoint modules or features. The position also requires following appropriate procedures and maintaining awareness of good manufacturing practices, safety, and regulatory guidelines such as cGMP and GLP.

The specialist manages cGMP records, including specifications, testing results, SOPs, test methods, change controls, testing documentation, and qualification and validation documents. The role administers Singlepoint, Trackwise, Tutela, and Shimadzu Lab Solutions; maintains related procedures and user documents; and creates and distributes training materials for system features and enhancements. Additional duties include maintaining the Quality Department training matrix for QA, QC, and Microbiology, organizing training records, and coordinating documentation for analytical testing by third-party laboratories.

Requirements

• Minimum associate’s degree in Secretarial Sciences, Business Administration, or Natural Sciences.
• Strong competency with document management software systems, Microsoft Excel, and Microsoft Word.
• Excellent organizational skills and ability to multitask.
• Detail-oriented, with excellent listening, oral, and written communication skills.
• Excellent interpersonal and team-building skills.

Nice To Haves

• Knowledge of Syncronology SinglePoint.
• Knowledge of current GMPs for the pharmaceutical, medical device, and cosmetics industries.
• One to three years of experience as a document control specialist in a regulated industry is preferred.

Responsibilities

• Create, publish, review, and archive electronic and paper cGMP documents, including material control records, specifications, testing results, SOPs, test methods, change controls, testing documentation, and qualification and validation documents.
• Administer Singlepoint, Trackwise, Tutela, and Shimadzu Lab Solutions quality software applications.
• Manage software user access and system changes through the change control process.
• Assist with troubleshooting system problems and resolving user issues.
• Support software qualification and validation by preparing required documents and executing test scripts as needed.
• Assist with identifying, developing, and qualifying new Singlepoint modules or features.
• Maintain Singlepoint-related SOPs and user documents based on the latest production version.
• Create and distribute training materials about new software features or enhancements to company users.
• Maintain the Quality Department training matrix for QA, QC, and Microbiology, including organizing completed training documents and updating the spreadsheet.
• Coordinate and prepare documentation needed for analytical testing of materials and products by third-party laboratories.
• Follow appropriate procedures and comply with applicable cGMP, GLP, and safety requirements.

What This Job Offers

• Job Type: Full-time
• Education Level: Associate degree