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 related field.
• Minimum of 2 years of cross-functional experience in areas such as research, analytical/QC, QA, stability, supply chain, manufacturing, CMC, IT, etc.
• Basic knowledge of document management, change control, and strong familiarity with QC type documents (methods and specifications for product testing).

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.