Senior Documentation Control Specialist

Summit Therapeutics • Palo Alto, CA

5d • $97,000 - $114,000

About The Position

Reporting to the Director, Quality Systems, the Documentation Support Specialist will be supporting GxP operations at Summit. Reporting to the Director Quality Systems, the role encompasses a range of duties including the following:

Requirements

• Minimum of 5 years of experience in a biotech or pharma industry.
• Bachelor’s degree in science/life science related field and/or pharmaceutical sciences.
• Must have excellent verbal and written communication skills.
• Must be highly organized with a strong attention to detail.
• Intermediate to advanced skills in MS Office Suite (Outlook, Excel, Word, PowerPoint).
• Ability to work with minimal guidance; Proactive, motivated self-starter.
• Understands pertinent regulations for the industry, for example, GLP, GCP, and 21 CFR Part 210, 211, and 820, ICH Guidelines, etc.
• Minimum of two years in Quality Assurance in the Pharmaceutical/Biotechnology industry.
• Experience in maintaining GXP training records, materials, or courses.

Responsibilities

• Support Quality team managing the electronic quality management documentation management system including uploading and archiving documents and handling associated requests
• Delivers the ‘Service Owner’ role for the electronic Quality Management System to ensure the system is used by the wider organization and any error reporting is handled in an effective manner. Also ensures ongoing development and enhancement of the toolset to meet evolving business requirements.
• Checks / maintains the compliance and quality of the documents, in relation to Standard(s), Guidance and Summit’s procedures and expectations
• Responds to documentation enquiries, giving appropriate access to information
• Supports other functions in drafting, reviewing and approving documents / records using the QMS
• Supports the ongoing maintenance and improvement of standard operating procedures and user guides
• Reports on progress of documents ensuring that documents are reviewed and approved within the review cycle
• Supports in any other tasks as deemed appropriate by the Line Manager.
• Support with QC checks for Regulatory and Safety team.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level