QA Documentation Manager

QA Documentation Manager - Contract - New Haven, CT

Proclinical is working alongside a pharmaceutical company seeking a QA Documentation Manager to join their growing team.

Primary Responsibilities:

The successful candidate will oversee the maintenance of a controlled documentation system, ensuring compliance with regulatory standards and corporate policies. This role involves technical writing and editing within a modern software development environment. Key responsibilities include tracking and reviewing change control documentation and assisting in the editing of quality documents such as Standard Operating Procedures (SOPs), guidelines, policies, and work instructions.

Skills & Requirements:

• Strong interpersonal and information-gathering skills for effective communication at all organizational levels.
• Proficient in technical writing and strong time management skills.
• Strong root cause analysis skills with experience in quality standards.
• Ability to establish working relationships with support areas to gather necessary information.
• Proficient in the Veeva Document Management System, including templates, workflows, and approval processes.
• Proficient in MS Word, Excel, PowerPoint, and Outlook.

The QA Documentation Manager's responsibilities will be:

• Design, develop, and update change control documentation.
• Perform technical writing and editing for various documents in the Veeva Document Management System.
• Track and review change control documentation to ensure compliance with regulatory requirements.
• Assist in editing quality documents such as SOPs, guidelines, and work instructions.
• Review current documents and incorporate feedback from project leaders and subject matter experts (SMEs).
• Navigate the Veeva Document Management System using existing templates.
• Communicate workflow status and issues to document authors and business owners.

Compensation:

• $30.00 - $41.00 Per Hour

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.