Quality Assurance Specialist

50% onsite

PURPOSE AND SCOPE OF POSITION (Position Summary) :

The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Vector External Manufacturing. Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards. This role directly supports release of vector timeline from the date of manufacture and will support all activities for routine clinical and commercial product release with an emphasis on supporting CMO with a Quality perspective within a regulated cGMP environment.

The primary focus of the QA Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture by ensuring documentation is complete, accurate and that batch records are executed in accordance with approved and effective standard operating procedures and specifications.

QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities) :

Education : Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree

Experience :

• 3-5 years of relevant cGMP experience. Experience in FDA / EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Hands-on experience with batch record review and product disposition is preferred.
• Strong computer skills with Word and Excel and other electronic manufacturing systems.
• Detail oriented team player with effective planning, organization, time management and execution skills.
• Proven experience working on teams where combined contribution, collaboration, and results were expected.
• Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
• Ability to work in a high paced team environment.
• Strong written and verbal skills.

Licenses / Certifications : N / A

ROLES AND RESPONSIBILITIES :

WORKING CONDITIONS (US Only) :

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.