Job Title: Quality Assurance SpecialistJob Description

The Quality Assurance Specialist will be responsible for supporting the Quality Assurance department with the review and approval of documents and records. Core responsibilities will relate to batch disposition and supporting the execution and phase-appropriate improvement of the quality management system.

Responsibilities

• Review and approve batch documentation prior to and after execution.

• Coordinate with cross-functional groups to complete batch disposition activities for starting materials, drug substance, drug product, and finished drug product.

• Resolve issues related to disposition.

• Actively monitor and manage training, quality event, and change control records to support timely completion of workflow activities by functional and quality assurance personnel.

• Support Quality and Supply Chain personnel with clinical drug product shipment, material transfer, and inventory management activities as necessary.

• Support Qualified Person (QP) and Authorized Person (AP) certification of product for geographies where necessary.

• Document archival in the electronic Quality Management System (eQMS).

• Review and approve documents related to the quality system.

• Author change control records.

• Initiate and manage document approvals in ZenQMS or DocuSign.

• Assist with the review and execution of internal quality events such as CAPAs, change controls, and attend internal/external cross-functional meetings as required.

• Provide aid with risk mitigation activities or path-forward discussions.

• Review and approve complaint investigations, internal audits/assessments, FDA response coordination, gap analysis, and regulatory inspection readiness.

• Contribute to continuous improvement actions within the Quality Assurance department.

• Work with cross-functional teams to manage deliverables and timelines.

Essential Skills

• Experience with quality assurance, batch record review, deviations, change control, and quality management systems (QMS).

• Proficiency in ZenQMS and GMP (Good Manufacturing Practice) requirements.

• Strong analytical, problem-solving, and decision-making skills.

• Excellent project management and organizational skills.

Additional Skills & Qualifications

• Qualified Person (QP) or Authorized Person (AP) certification.

• Experience working with contract manufacturers and test labs.

Work Environment

The Quality Assurance Specialist will work in a patient-focused environment aiming to be a center of excellence across a given disease spectrum. The role involves collaboration with experts in science, technology, disease management, and care. The work setting is dynamic, requiring interaction with cross-functional teams and adherence to regulatory standards. The position supports activities such as clinical drug product shipment, material transfer, and inventory management. Dress code is business casual.

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.