
Documentation Support Coordinator
- Lincoln, NE
- Permanent
- Full-time
- Prioritize workload on a daily basis to respond to the changing Manufacturing schedule.
- Maintain a safe work environment and participate in Site Safety program initiatives.
- Work with Manufacturing and VMRD to update Batch Records and other Manufacturing GMP Documents according to site change control procedures.
- Maintain Central Documentation databases.
- File and archive GMP records using Central Documentation systems according to SOP and Zoetis Record Retention Policy
- As needed, assist with retrieving GMP records during inspections (i.e., Batch Records, Protocols, etc.)
- Manage issuance and archival of notebooks and logbooks.
- Assist with other group activities as requested, these activities are not limited to but may include use/support of quality systems (Veeva Vault, ETS, LMS, and SAP), support of annual product review, risk assessments, change control, stability program and regulatory inspections.
- Perform other duties and special projects, as assigned.
- Associate degree or equivalent post high school education or equivalent experience
- 1-2 years relevant work experience preferred.
- Advanced proficiency in Word and Excel Microsoft applications
- Strong time management skills with proven experience in multi-tasking and prioritization
- Process and detail oriented with the ability to follow complex processes and prepare detailed structured documents.
- Demonstrated organizational and administrative skills and the ability to communicate effectively with multiple organizations.
- Ability to work within a Team and Independently
- Working knowledge of US-FDA, EU, and International Registration requirements
- Experience in change management processes, manufacturing operations, quality operations, and/or regulatory affairs.
- Experience with Training Documentation Systems, Quality Tracking Systems, Laboratory Information Management Systems and Manufacturing Planning Systems
- Experience in Access, SharePoint, Microsoft Teams & SAP applications.