Document Control Coordinator

Endo • Raleigh, NC

4d • Hybrid

About The Position

The Documents Control Coordinator serves as a documentation technical resource to the plant. She/he is the primary point of contact for the controlled document and related processes. Also serves as a back-up to Batch Record Review. This position oversees and administers the controlled document process for the site, ensuring compliance of the system with FDA regulations and company policies and procedures. Serves as the DMS administrator for the software system used to electronically house the Site’s documents. Provides training to employees on how to use the system. Coordinates DMS related projects and improvements. Provides timely processing and administration of controlled documents. Provides word processing assistance to departments to ensure controlled documents and batch records are formatted consistently. Monitors completion status of periodic reviews and change control action items to ensure timely documentation of actions and maintain compliance. Periodically audits master copies of documents to ensure issued copies are current. Enters all revised documents into the Learning Management System in a timely manner so training can be conducted. Proofs APAP finished lot labels and batch records. Back-up for label administration including program label changes, adding new codes to labeling computer, and conducting label audit trails. Supports annual DMF updates. Provides support to investigations, both exceptions and OOS’s to support product disposition. Provide support to intermediate labeling and tank inspections as needed. Provides administrative duties for the department, such as mail distribution, coordination of supplies, and maintenance for the fax and copy machines. Participates in a certified 5S Workplace System to ensure good housekeeping and organization.

Requirements

• High school diploma, GED, or equivalent required.
• Competency in MS Word, Excel, and Adobe is required.
• 1-3 years pharmaceutical manufacturing experience is preferred.
• Experience using an electronic document system is preferred.
• Organization, follow-through, effective communication, and computer literacy.
• Action Oriented, Conflict Management, Customer Focus, Functional / Technical Skills, Presentation Skills, Priority Setting, Written Communication
• Demand for labels and record retrieval creates interruptions.
• A high degree of concentration is required to prevent mix-up and consequent errors.
• This position requires self-motivation and daily execution of tasks with limited supervision interaction.

Nice To Haves

• Associate/Technical degree or higher preferred.

Responsibilities

• Oversees and administers the controlled document process for the site, ensuring compliance of the system with FDA regulations and company policies and procedures.
• Serves as the DMS administrator for the software system used to electronically house the Site’s documents.
• Provides training to employees on how to use the system.
• Coordinates DMS related projects and improvements.
• Provides timely processing and administration of controlled documents.
• Provides word processing assistance to departments to ensure controlled documents and batch records are formatted consistently.
• Monitors completion status of periodic reviews and change control action items to ensure timely documentation of actions and maintain compliance.
• Periodically audits master copies of documents to ensure issued copies are current.
• Enters all revised documents into the Learning Management System in a timely manner so training can be conducted.
• Proofs APAP finished lot labels and batch records.
• Back-up for label administration including program label changes, adding new codes to labeling computer, and conducting label audit trails.
• Supports annual DMF updates.
• Provides support to investigations, both exceptions and OOS’s to support product disposition.
• Provide support to intermediate labeling and tank inspections as needed.
• Provides administrative duties for the department, such as mail distribution, coordination of supplies, and maintenance for the fax and copy machines.
• Participates in a certified 5S Workplace System to ensure good housekeeping and organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED