Job Title: Document Control Administrator III

Job Description

As a Document Control Administrator III, you will play a crucial role in ensuring detailed documentation processes, supporting our mission to deliver extraordinary solutions. You will be instrumental in managing and maintaining comprehensive document control systems within a regulated environment.

Responsibilities

• Scan and archive batch records and other cGMP documents.
• Organize, pack, ship, and receive batch records.
• Perform sample and product label creation and cancellation using SAP and Sample Manager systems.
• Issue and prepare logbooks, batch records, high-risk forms, and other cGMP documents with 'right the first time' execution.
• Conduct review processes and assign effective dates to batch records and other cGMP documents.
• Execute all document-related tasks such as making documents effective, printing, periodic review, withdrawal, reconciliation, issuance, archiving, scanning, record retention, document release, and accountability.
• Document all activities to meet cGMP requirements.
• Maintain cGMP compliance in assigned work and follow all safety procedures, including the use of Personal Protective Equipment, if required.
• Perform basic routine cleaning and organizing of archive rooms.
• Complete reconciliation processes of driven batch records and other cGMP documents.
• Participate in cross-functional activities.
• Maintain up-to-date training records.
• Engage in other required activities, such as performing safety inspections, participating in improvement projects, and other documentation processes.
• Participate in shift exchanges, one-on-ones, and meetings.
• Be available for on-call coverage during off-shifts.
• Train on the first shift to learn crucial job functions for a reasonable period of time.

Essential Skills

• Proficiency in document control and Microsoft Office.
• Experience in a GMP or regulated industry.
• Understanding of quality management systems, including change control, deviations, documentation management, and training systems.
• Experience with electronic Quality and Training Management Systems, quality control, inspection, and change control.

Additional Skills & Qualifications

• High school diploma or equivalent experience required.
• At least 1 year of experience with batch record review and GMP documentation in a pharmaceutical GMP regulated environment.
• Understanding of cGMP practices and proper documentation procedures preferred.
• Proficiency in MS Office and Smartsheet.
• Ability to effectively multi-task and communicate clearly.

Work Environment

The role requires good hand and finger dexterity for typing, and clear vision for using a computer and reading. The work hours are Monday to Friday, 6 am to 2:30 pm. Our team fosters a culture dedicated to impactful work and innovative thinking. We prioritize working the right way, for the right reasons, with the customer always in mind. Our commitment is to provide resources and opportunities for career growth in a fast-growing, global organization.