Quality Systems Specialist

Description:

Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals.. Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing local and global change controls and associated activities related to GxP operations. m Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS expectations. Navigate through complex change review discussions, facilitating to a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly.

Supports management and monitoring of change records for adherence to organizational or departmental metric targets, and maintenance of associated tracking tools/databases. Supports management review process through development and generation of quality system metrics and trending, and escalates issues as required. Supports the maintenance and improvement of quality systems processes, as needed.

Works directly with operating entities and internal clients to ensure follow-up of change tasks. Participate in compliance audits as required. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs). Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.

Skills:

Quality assurance, Gmp, Document control, Change control

Top Skills Details:

Quality assurance,Gmp,Document control,Change control

Additional Skills & Qualifications:

6+ years of relevant experience in a GMP environment for biologics manufacturing and a BS or BA, with change control experience a must. 4+ years of relevant experience and a MS.

Experience Level:

Intermediate Level

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 for other accommodation options.