Documentation and Training Specialist (Pharmaceuticals)

Location: Middletown, Delaware, United States; on-site in a GMP manufacturing environment

Company

WuXi STA is establishing pharmaceutical manufacturing capability and the quality systems required to support OSD and sterile drug-product operations.

What you will do

• Administer controlled GMP documents through formatting, approval routing, issuance, revision, supersession, archival, and reconciliation.
• Support SOP, work-instruction, form, template, and job-aid development for OSD and sterile or aseptic manufacturing operations.
• Coordinate GMP training curricula, matrices, assignments, due dates, retraining, qualification status, and learning-management records.
• Review document and training records, identify discrepancies and overdue actions, and support investigations and escalations.
• Support new product introduction, technology transfer, change activities, and operational readiness by coordinating document revisions and training assignments.
• Prepare approved GMP and Good Documentation Practices training, coordinate instructor-led sessions, and compile document-control and training metrics.

Requirements

• Bachelor’s degree in a scientific, engineering, quality, education, business, or related discipline, or equivalent relevant experience.
• Approximately two years of related experience in pharmaceutical or biopharmaceutical document control, training administration, quality systems, or a comparable area.
• Experience supporting documentation and/or training in a GMP pharmaceutical manufacturing environment is required.
• Knowledge of controlled-document and training lifecycles, applicable GMP requirements, quality-system procedures, and validated electronic document-management or learning-management systems.
• Strong Good Documentation Practices and data-integrity discipline, including ALCOA+ principles, accuracy, traceability, and record completeness.
• Ability to work with limited day-to-day instruction, collaborate cross-functionally, support audits and inspections, and manage multiple priorities.

Nice to have

• Experience in a GMP manufacturing environment and familiarity with quality, training, or records-management certification.
• Experience with training matrices, curricula, qualification tracking, periodic reviews, and trend reporting.

Culture & Benefits

• Build-stage environment with evolving procedures, systems, and priorities.
• Cross-functional collaboration with quality, manufacturing, engineering, validation, and other functions.
• Work combines computer-based documentation and training-system activities with occasional standing, walking, and on-floor manufacturing support.
• Focus on a “Right First Time” culture and consistent execution of approved procedures.