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About the Role
Support Quality Assurance (QA) activities including maintenance and organization of the Central File system, issuance of documents, review and release of Batch Records, and support of MasterControl tasks, all in accordance with current Good Manufacturing Practices and 21 CFR 210/211.
Responsibilities
- Generate and issue controlled documents, including Batch Record documents/forms, specifications, and logbooks.
- Review lot-specific documentation for Batch Production Records to confirm accuracy, completeness, and compliance.
- Confirm disposition of batch-associated nonconformances and quality events prior to batch release.
- Identify and route documents for corrections when documentation is missing or incorrect.
- Collaborate with company personnel to correct identified mistakes.
- Use ERP system to select proper disposition of individual batches and notify of availability for distribution.
- Generate controlled labels for manufacturing and packaging processes.
- Review logbooks as needed.
- Maintain and control the Central File system for paper-based documents.
- Prepare the department for internal and external audits.
- Retrieve documents from filing systems during audits.
- Control department inventory for supplies related to batch records, document issuance, and the central filing system.
- Support Document Collaboration and Set Dates for document creation/revisions.
- Support the maintenance and control of electronic document archival within MasterControl Software.
- Build and maintain collaborative working relationships within the organization.
- Communicate effectively throughout all facets of the organization.
- Follow and solicit good manufacturing and documentation practices.
- Support QA activities as needed.
- Support Quality Management System continual improvement initiatives.
- Triage workflow to ensure first-in, first-out or priority release of finished product or product-dependent documents.
- Perform other activities and tasks as dictated by departmental and organizational needs.
Requirements
- A High School diploma or equivalent.
- A minimum of 1 year of experience in a regulated environment (Pharma or other medical preferred).
- Proficiency with computers.
- Knowledge of standard Microsoft Office suite, email, and document scanning.
- Strong Excel and Word experience.
- Knowledge of GMPs.
- Knowledge and experience with organization and filing of controlled documents.
- Knowledge and experience with the use of electronic Quality Management Systems.
- Ability to work independently and as part of a team.
- Attention to detail.
- Self-motivated and organized.
Skills
- Microsoft Office Suite
- Excel
- Word
- Document Scanning
- ERP system
- MasterControl Software
- Interpersonal Communication
Experience Level
- 1 year experience
Education Level
- High School diploma or equivalent
- Associate degree
- Bachelor degree in Science/Life Sciences