Job Description

Job Description

Job Description

The Document Controller provides customer service for the record center and printed and electronic document control management, and other administrative duties in support of our corporate client’s records management needs. This is achieved by the issuance, distribution, reconciliation, labeling and filing of good manufacturing practice (GMP) documentation, security paper and logbooks, including updating and maintaining document tracking databases and archival systems, in alignment with document requirements.

The position is located onsite at our pharmaceutical client’s Research Triangle Park offices and will require some planned overtime, including periodic on-call weekends, as needed to support internal or external audits and other business needs during client site shutdowns.

What you will be doing:

• Perform document control for all documents and records maintained in Veeva Quality Docs Electronic Data Management System (EDMS).
• Assist in support of processes for updating, routing, and approval of electronic documents
• Periodically meet with internal personnel to review documents and assign Veeva Quality Docs meta data when adding documents into the Veeva Quality Docs EDMS.
• Manage retention of GMP related records in accordance with document type and Record Class Codes.
• Manage and facilitate reconciliation process for executable electronic and paper records.
• Facilitate binding, issuance, and reconciliation of paper logbooks.
• Support external and internal audits through providing readily accessible records as requested for review by regulatory and internal auditing teams.
• Monitor and perform document periodic reviews within Veeva Vault Quality Docs according to standards and procedures.

Requirements

• Associates or Bachelors degree desired or equivalent experience in a records/documentation center
• Previous experience in records management, data entry, or similar experience.
• 1-3 years of relevant experience in the pharmaceutical/biopharmaceutical industry, a plus
• Strong knowledge of computer applications in the Microsoft Office suite
• Experience working in an environment that adheres to strict standard operating procedures
• Extraordinary attention to detail and follow-through. Self-directed and motivated with ability to work independently as well as collaboratively in a team environment.
• Ability to climb stairs, bend and reach for filing, lift up to 30 lbs. as part of moving/organizing file boxes
• Will be required to pass a drug screen and background check

A pioneer in voluntary collective licensing, CCC is a leading information solutions provider to organizations around the world. CCC works to advance copyright, accelerate knowledge, and power innovation. CCC helps organizations harness the power of data, AI, and machine learning to drive strategic decision-making, grow their businesses, and gain competitive advantage.

When you join CCC, you become part of a dynamic organization strengthened by our community. We care about our team members and clients. We strive to create advanced technology in a vibrant, innovative culture. CCC provides excellent benefits.

CCC is an Equal Opportunity, Individuals with Disabilities and Protected Veterans Affirmative Action Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and/or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and/or veteran status, and any other characteristic protected by applicable law.

If you need accommodation for any part of the employment process because of disability, please let a member of our HR Department know the nature of your request.

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