Documentation Specialist

About the Role

Management of commercial specifications and methods (internal release, stability, regulatory and compendial), and supporting documents for all client drug products, drug substances, intermediates, starting materials, excipients, reagents, and packaging components. This includes quality assessment of change proposals to create new or revise commercial specifications and methods.

The primary responsibility of the candidate will be to perform content review of change controls, including global testing standards (GTS) and test method documents.

Responsibilities

• Manage commercial specifications and methods to ensure clear, correct, concise, consistent, and compliant documentation.
• Review and execute change proposals for GTS documents.
• Perform quality approval of GTS documents.
• Maintain the GTS system, including managing notification templates and obsolescing documents that are no longer in use.

Qualifications

• Minimum of a bachelor’s degree is required.
• Minimum 4 years of experience in the pharmaceutical industry or a related field.
• Cross-functional experience in two or more areas (e.g., research, analytical/QC, QA, stability, supply chain, manufacturing, CMC, IT, etc.).
• Knowledge of specifications/methods, compendia, cGMP requirements, and regulatory expectations.
• Document management experience in a systems-related environment.
• Change management experience.
• Experience with SAP or Lab Information Management systems.

Skills

• Ability to set priorities and deliver results independently.
• Customer and partner focus, including the ability to listen to and incorporate feedback (as appropriate) from key stakeholders.
• Ability to influence, initiate, and manage change.
• Organization awareness and ability to work well cross-functionally with R&D, Regulatory, IT, etc.
• Detail-oriented with a quality mindset.
• Strong verbal and written communication skills.
• MS Office experience.
• Excellent meeting facilitation and project management skills.