Quality Assurance Coordinator
Job Description
The Quality Assurance Specialist – Validation Coordinator is responsible for managing validations related to manufacturing product, process, equipment, laboratory, and facility, contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance.
In this critical QA role, you will lead as a Subject Matter Expert in a newly formed CDMO quality assurance team that thrives on exciting science and collaboration with internal and external partners.
This newly created position has the opportunity to engage in a variety of projects at various stages of development, but primarily focuses on Phase 3 and commercial Quality Assurance through the direct project management of varying complexities of equipment, test method and process validations initiated for the GMP operations of a newly constructed manufacturing facility.
In addition, this specialist will support site validation activities as a QA SME in the review and approval of quality documentation for these activities.
Review/Manage equipment, process, and test method validations, and Quality review and approval associated activities for a newly constructed cell and gene therapy CDMO facility.
Support Regulatory Agency submissions and audits by being a Subject Matter Expert in the assigned area.
Review and audit complex documents: batch records, GMP protocols, process and method validations in compliance with QMS, policies, and procedures.
Observe manufacturing activities to support the implementation of best practices and improvements, including the transfer of site knowledge to new facility startup activities.
Support technology transfer initiatives, as assigned.
Manage QMS; author, review, and approve SOPs and Policies for the new facility.
Prepare routine updates and project status reports of Quality Assurance activities.
Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
Ensure that documentation is maintained in accordance with internal procedures and regulatory requirements.
Support, prepare, and provide Quality training with cross-functional teams as assigned.
Hard Skills
Quality Assurance
Biology
Microbiology
Investigations
Deviations
GMP
Technical Writing
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions.
We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.
With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people.
DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ****** (%20******) for other accommodation options.