Document Control Associate

Zoetis • Charles City, IA

11d

About The Position

The Document Control Associate performs the day-to-day functions of the Document Control department, provides progress updates to the QA Team Lead on personal objectives, and reports deficiencies or issues within their areas of responsibility. The role supports controlled-document workflows, record management, production documentation, EU release documentation, and timely responses to manufacturing and regulatory inspection needs. It requires coordinating with production colleagues, maintaining document throughput, making risk-based decisions when a team leader is not present, and participating in the department’s on-call schedule.

The position is full-time and regular. It requires extensive computer work, the ability to work a scheduled 40-hour week and overtime as needed, and physical activities including prolonged sitting, walking or standing, lifting up to 50 pounds, reaching, bending, stooping, kneeling, pushing, pulling, gripping, and repetitive hand and wrist movements.

Requirements

• Minimum of two years of college education or equivalent experience.
• Previous experience with governing regulations and an understanding of how they apply to the business.
• Organizational, teamwork, innovative-thinking, attention-to-detail, and quality skills.
• Understanding of Document Control job functions and responsibilities, as described in departmental policies and procedures and qualifications.
• Background in Document Control or a basic understanding of the business’s operations and paperwork flow.
• Computer experience with Outlook, Word, Excel, Access, Adobe Acrobat, and SAP.
• Ability to work a scheduled 40-hour week and overtime as needed.
• Ability to lift 50 pounds and meet the stated physical requirements.

Responsibilities

• Provide updates to the QA Team Lead on progress toward personal objectives and report identified deficiencies or issues.
• Complete EU release documents, including Batch Release Protocols (BRPs) and Passbills.
• Issue and reconcile controlled documents according to production work schedules, including batch records, Veeva Vault documents, and logbooks.
• Finalize controlled documents, including batch records and Veeva Vault documents.
• Promote documents into electronic systems, including batch records and Veeva Vault documents.
• Type necessary documents and revise department policies, procedures, and logbooks.
• Archive and scan completed batch records and raw material packets; archive logbooks, master documents, and other records.
• File documents and retrieve archived records for manufacturing, complaints, and inspections.
• Reconcile manufacturing paperwork into Document Control files.
• Destroy documents after their retention period has been reached.
• Provide backup release support for semi-finished goods, antigens, seeds, and medias.
• Promote teamwork and innovative thinking, and identify and implement improvements while managing workload, objectives, and individual development.
• Coordinate needs with production colleagues through strong communication.
• Apply attention to detail and perform tasks right the first time.
• Manage projects and support collaboration and consistency between sites through strong organizational skills.
• Issue status reports to departments as outlined in standard operating procedures.
• Provide requested documents for regulatory inspections in a timely manner.
• Manage time to maintain document throughput and avoid backlogs; make risk-based decisions without a team leader present.
• Cross-train in all aspects of Document Control functions.
• Participate in the department on-call schedule.

What This Job Offers

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