Quality Assurance Specialist

Job Description:
As a part of our Quality Assurance team, you will play a crucial role in supporting our mission to deliver groundbreaking therapies by ensuring the highest standards of document control and compliance within our cGMP operations.

Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist is integral to our Cell Therapy Above-site organization, providing essential support for our cGMP Document Control operations. This role is perfect for a self-motivated individual with a keen eye for detail and a passion for maintaining the integrity and effectiveness of document control processes.

Key Responsibilities:

• Manage the electronic document management system, including reviewing, approving, and troubleshooting document change requests, and releasing documents to an effective state.
• Participate in writing, revising, and rolling out document control procedures and tools.
• Ensure compliance with Policies, SOPs, and work instructions throughout the document approval process.
• Assist in cross-training Document Control personnel and customers.
• Oversee the process for identifying, collecting, distributing, and filing controlled documents.
• Generate reports for Quality Council metric reporting.
• Support internal and external audits and regulatory inspections, including document retrieval and organization.
• Communicate status updates of Quality Systems deliverables to customers, management, and stakeholders.
• Employ technical writing skills to critically review documents and articulate Quality principles effectively.

Who You Are:

• You have at least 2 years of Document Control & Reporting Experience, preferably in a cGMP/FDA regulated environment.
• You possess a Bachelor’s degree or equivalent in a relevant field.
• Veeva system experience is preferred.
• You are technically adept, capable of troubleshooting and have strong computer skills, including proficiency in MS Office and Quality Systems (e.g., Document Management System, Quality Management System).
• An independent and self-motivated worker with excellent communication skills and the ability to work cross-functionally.
• You have a proven track record of being innovative, proactive, and resourceful, with a commitment to quality and continuous improvement.
• Capable of prioritizing tasks, managing time efficiently, multitasking, and troubleshooting effectively.
• You have experience with FDA or other regulatory agencies and a strong understanding of cGMPs and regulatory requirements.