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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Document Management, including authoring and revising documents in compliance with cGMPs and regulatory requirements. Proficient in coordinating document processing and conducting training, while effectively collaborating with cross-functional teams to enhance quality systems.
Highest-signal resume keywords
Qualified AuthorQuality Control ExperienceCGMP ComplianceDocument Management System (Aizon)Data Analysis and Reporting
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Document AuthoringChange Control ManagementRisk Assessment CoordinationElectronic Batch Record ManagementQuality System Improvement
Soft Skills
Excellent Written CommunicationExcellent Verbal CommunicationIndependent Decision-MakingCollaborationTraining and Development
Tools & Technologies
Document Management SystemAizonCosmos
Industry Keywords
CGMPCGDocPBLARegulatory RequirementsQuality Standards
About the role
Key responsibilities & impact- Maintain Qualified Author status to author and revise documents according to governing SOPs
- Coordinate development, maintenance, review, routing, publishing, periodic reviews, and historical file management for BPRs, SOPs, and EBRs in the Document Management System and Aizon
- Review and evaluate documentation for compliance with cGMPs, cGDocPs, BLAs, regulatory requirements, and site quality standards
- Coordinate document processing for Risk Assessments, Manufacturing Methods, Project Plans, and related documents
- Execute changes to electronic batch record Master Recipes in Aizon
- Process periodic document reviews and distribute reviewer notifications before due dates
- Conduct instructor-led training classes for author qualifications
- Author, revise, review, route, and/or approve Change Control Requests, incident entries, and investigation reports
- Represent Quality Document Management in discussions and meetings with other business groups
- Collaborate with Manufacturing, Quality Assurance, Quality Control, Validation, and other departments on projects, investigations, CAPAs, change controls, and quality-system improvements
- Update document profiles and the Document Management System; generate, review, and post reports to Cosmos
- Assist with site regulatory inspections and customer audits
- Consult with management to develop and implement quality-related solutions
- Support deployment of technical resources toward annual goals
- Make independent decisions within defined responsibilities
- Lead or participate in multidisciplinary project teams and advance technical project proposals to senior management
- Collect and analyze data to generate overview reports
- Participate in internal and supplier compliance audits and failure investigations
- Perform other duties as assigned
Requirements
What you’ll need- BA/BS, preferably in a STEM (science, technology, engineering, or mathematics) curriculum, and 5 years of relevant experience, or an equivalent combination of education and experience
- Directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements
- Quality Control experience and/or knowledge of QC relevant documents preferred
- Qualified Author preference
- Excellent written and verbal communication skills
- Basic knowledge and understanding of domestic (e.g., US Food and Drug Administration CFR) and applicable foreign regulatory agency requirements and guidelines
- Ability to independently develop and implement solutions to quality-related objectives
- Ability to execute assignments of medium complexity and develop solutions for defined problems
- Ability to lead or participate on multidisciplinary project teams
- Ability to collect and analyze data and generate reports
- Ability to work with cGMPs, cGDocPs, BLAs, regulatory requirements, and quality standards
- Minimal supervision as a fully qualified professional
Benefits
Comp & perks- Regular full-time employment
- Day shift schedule
- Equal employment opportunities and consideration consistent with applicable laws