Senior Associate, Quality Assurance - Temporary Contract

The role

The Senior Quality Assurance Associate supports early phase cell and gene therapy clinical GMP manufacturing operations. They execute operational elements of the Quality Management System and collaborate cross-functionally to ensure cGMP compliance.

What you will do

• Assist in executing QA responsibilities to support material and product release.
• Develop, implement, and maintain a phase appropriate Quality Management System through creation, review, and approval of documentation.
• Partner with Manufacturing and Quality Control to review and edit documentation such as batch records, methods, validation protocols, reports, and testing data.
• Support the continuous improvement and oversight of Quality Management System procedures.
• Assist with company-wide understanding and adopting GMP / GDP practices.
• Actively participate in fostering a positive, collaborative work culture.
• Support other QA functions with other projects and tasks.

Required qualifications

• BS or equivalent in life science or related field and 5+ years industry experience in manufacturing/testing (GMP) and/or clinical (GCP) Quality Assurance; or equivalent combination of education and ex
• Knowledge of FDA regulations and standards, especially those pertaining to cell therapy, gene therapy, bioanalytical testing, and clinical research.
• Experience authoring, reviewing, and/or approving procedures, policies, work instructions, and any other related controlled documentation.
• Experience authoring, reviewing, and/or approving quality events such as deviations and laboratory investigations/OOS/OOT.
• Exceptional communication and interpersonal skills.
• Exceptional oral and written communication skills to all organization levels as well as clients and vendors.
• Strong organizational skills; able to prioritize and manage through complex processes/projects.
• Ability to be hands-on and detail orientated.
• Proficient in MS Office application suite as well GMP electronic applications such as QMS / LIMS.
• Effectively manages cross-functional communication.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to work independently and stay on task in a fast-paced environment.

Nice to have

• Experience with administrative access using Veeva as a document control and training management system
• Veeva document management and vault training manager experience

About the company

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers. They provide technical expertise and GMP infrastructure across autologous and allogeneic therapies.