QUALITY ASSURANCE SPECIALIST - Actalent : Job Details

Job Title: Quality Assurance Specialist

Job Description

Looking for a Quality Assurance specialist to support day-to-day operations for the commercial assurance team. This individual will handle document issuance and batch review for commercial testing and manufacturing. They will manage product complaints, project activities, and quality systems related to commercial manufacturing. Responsibilities include performing document issuance for testing and manufacturing, assuring appropriate reconciliation of documentation, and conducting thorough documentation reviews, including non-conformance events/deviations, data analysis, and executed batch records, using working knowledge of cGMPs and internal procedures and controls. The specialist will provide final product disposition determination, aid in the coordination and maintenance of Quality Programs such as Change Management, Non-Conformances, CAPA, Complaints, Annual Product Reviews, and Management Reviews. They will also maintain expertise in one or more QA disciplines to perform analysis and draw conclusions, identify and resolve quality issues in consultation with management and other departments, engage with internal and external organizations to meet batch release timelines, provide support for regulatory inspections and GMP audits, participate in planning and prioritization for resolving quality and compliance issues, author/review procedures within the Blood Product Quality Management System, and provide metrics and data-driven solutions to reduce the cost of quality and improve monitoring system efficiency for blood products.

Hard Skills

+ Experience working within Quality Management system - 3+ years

+ Quality Management System - 3+ years

+ CAPA/GMP experience

Soft Skills

+ Attention to detail

+ Problem-solving skills

+ Ability to engage with internal and external organizations

+ Coordination and maintenance of Quality Programs

+ Support for regulatory inspections and GMP audits

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 [email protected] ( [email protected]) for other accommodation options.