Documentation (QC) Specialist

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 in a relevant field.
• Minimum of 4 years of experience in the pharmaceutical industry or a related field.
• Cross-functional experience in two or more areas such as 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.

Capabilities

• Ability to set priorities and deliver results independently.
• Customer and partner focus, including the ability to listen to and incorporate feedback 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.