Documentation and Training Specialist - Pharmaceuticals
On-siteMiddletown, Delaware, United States
Job Summary
Administer controlled GMP documents through their lifecycle, including formatting, review, approval routing, issuance, revision, and archival in accordance with approved procedures. Support the development and maintenance of SOPs, work instructions, forms, and templates for Oral Solid Dosage and sterile drug-product operations, ensuring compliance with site standards. Coordinate GMP training administration, including curricula maintenance, assignment tracking, completion follow-up, and qualification status within the learning-management process. Perform routine document and training record reviews, identify discrepancies, contribute to initial investigations, and escalate exceptions as defined. Prepare and deliver approved GMP and document-control content for routine audiences, while compiling metrics and reports on overdue training and revision activity. Partner across quality, manufacturing, engineering, and validation functions to resolve documentation issues and ensure records meet ALCOA+ principles.
Required Qualifications
- Bachelor's degree in a scientific, engineering, quality, education, business, or related discipline, or an equivalent combination of education and directly relevant experience
- Approximately two years of related experience in pharmaceutical or biopharmaceutical document control, training administration, quality systems, or an equivalent combination of education and directly relevant experience
- Experience supporting GMP training administration, learning-management activities, training matrices, curricula, or qualification records in a regulated or manufacturing environment
- Demonstrated understanding of the controlled-document lifecycle and training lifecycle, including the importance of current procedures, traceable approvals, timely training, and accurate records
- Experience supporting documentation and/or training in a GMP pharmaceutical manufacturing environment
- Experience executing document changes, periodic reviews, document issuance and obsolescence, training assignments, and follow-up activities within defined procedures and practices
- Working knowledge of applicable GMP requirements and quality-system procedures, with the ability to apply them to routine documentation and training activities
- Strong Good Documentation Practices and data-integrity (ALCOA+) discipline, with close attention to accuracy, traceability, and record completeness
- Experience operating within validated electronic document-management and/or learning-management systems
- Strong written and verbal communication, with the ability to collaborate effectively with colleagues across functions and provide clear standard professional guidance on documentation and training requirements
- Ability to work with little instruction on day-to-day activities, exercise judgment within defined procedures for issues of moderate scope, and seek guidance on new, unusual, or higher-risk assignments
- Experience supporting internal, client, or regulatory audits and inspections through timely retrieval of controlled documents, training records, and supporting evidence
Desired Qualifications
- Experience in a GMP manufacturing environment
- Familiarity with document-control, training, or quality-system best practices
- Relevant quality, training, or records-management certification
- Familiarity with training matrices, curricula, qualification tracking, document periodic review, and routine metrics or trend reporting
- Organized, detail-oriented, and dependable in cross-functional interactions, with the ability to manage multiple routine priorities and follow through on commitments
- Familiarity with data-integrity, confidentiality, and security risks associated with using unvalidated AI tools for GMP documentation or training content
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