Our client is seeking a team of Quality Management Professionals to support a large expansion project to support their top diabetic sterile injectable drug. Day to day they will be in charge of:

• Support the project’s various documentation implementation (i.e. SOPs, Calibration Records, PMs, Batch Records) for associated work packages by key milestone deliverable dates defined within the expansion project scope

• Support authors in the writing process with language usage, document control process & related tool while ensuring documents are clear and reader friendly.

• Execute the local change process for documents with a focus on compliance with existing procedures in a way that guarantees ease of use for document owners, users, and quality approvers.

• Ensure adherence to the Project’s Quality Strategy and regulatory compliance

• Collaborate cross-functionally and maintain stakeholder relationships.

Support project’s monthly Quality Risk Reporting data gathering and report outs

Support the project’s weekly Quality KPI data gathering, report outs and mitigations, as applicable.

Skills:

• GMP

• Document control

• Quality management system

Additional Skills & Qualifications:

Document Management Procedures

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.