The Documentation and Training Specialist is a quality professional who supports the execution of GMP document control and training processes while the site’s quality systems are being established. This is a build role rather than a maintenance role: the Specialist helps create, route, issue, maintain, and reconcile controlled documents and training records required for Oral Solid Dosage (OSD) and Sterile drug-product manufacturing—including aseptic processing and drug-substance operations—and supports compliance with applicable GMP requirements and site procedures.

Working within established procedures and with guidance on new assignments, the Specialist applies learned techniques and judgment to resolve documentation and training issues of moderate scope, collaborates with cross-functional partners, and supports a “Right First Time” culture as the site progresses toward routine GMP operations. Work is performed with little instruction on day-to-day activities and general direction on new assignments.

Key Responsibilities

• Administer controlled GMP documents through their lifecycle, including formatting, review and approval routing, issuance, effective-date coordination, revision, supersession, obsolescence, distribution, reconciliation, and archival in accordance with approved procedures.
• Support the development and maintenance of SOPs, work instructions, forms, templates, and job aids for OSD and sterile/aseptic drug-product operations, checking document structure, metadata, numbering, references, and controlled status for compliance with site standards.
• Coordinate GMP training administration, including curricula and training-matrix maintenance, assignment of required training, due-date tracking, completion follow-up, retraining, qualification status, and accurate training records within the approved learning-management process.
• Perform routine document and training record reviews and reconciliations, identify discrepancies or overdue actions, contribute to initial investigation of issues, and escalate exceptions in accordance with defined procedures.
• Support site and operational readiness by tracking required controlled documents and training activities and helping ensure current procedures, forms, curricula, and training records are available before GMP activities begin.
• Support new product introduction (NPI), technology-transfer, and change activities by coordinating associated document revisions and training assignments so affected personnel receive current requirements before implementation.
• Prepare and deliver approved GMP, Good Documentation Practices, document-control, and training-system content for routine audiences, and coordinate instructor-led training logistics, attendance, and completion records.
• Compile routine document-control and training metrics and reports, including overdue training, document periodic-review status, revision activity, and completion trends, and provide initial analysis for review by experienced quality professionals.
• Ensure records are complete, attributable, legible, contemporaneous, original, accurate, consistent, enduring, and available in accordance with Good Documentation Practices and data-integrity (ALCOA+) principles, including appropriate use of validated document-management, learning-management, and other digital quality systems.
• Partner across quality, manufacturing, engineering, validation, and other functions to resolve routine documentation and training issues, coordinate required actions, and support consistent execution of approved procedures.

• 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 in a GMP manufacturing environment is preferred.
• 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. (Must have)
• 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.
• Familiarity with document-control, training, or quality-system best practices; relevant quality, training, or records-management certification is a plus.
• 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.

• Key Competencies
• Right First Time mindset: executes documentation and training activities accurately, completely, and on time, and raises issues when requirements are unclear or at risk.
• Collaborative, organized, and systematic; manages multiple assignments within defined priorities and contributes to practical improvements in routine processes.
• Clear communicator who adapts standard guidance to technical and non-technical audiences and builds productive working relationships across functions.
• Comfortable contributing in a dynamic, build-stage environment and adapting to evolving procedures, systems, and priorities.

• Work Environment and Physical Requirements
• Work in a GMP manufacturing environment.
• Periods of computer-based document and training-system work, with occasional standing, walking, and on-floor support during manufacturing activities.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.