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Description:

The incumbent is responsible to help operate within our new cGMP clinical manufacturing site. This role will work closely within the manufacturing and warehouse areas to receive, inspect, label, and store materials, and perform inventory, and support operations. The successful candidate will have experience in warehouse operations and/or manufacturing support operations, inventory management, and have a good understanding of Good Manufacturing Practices.

Key Role & Responsibilities:

Warehouse Operations:

• Participate in the development and implementation of processes related to warehouse operations.

• Work collaboratively with Manufacturing, QA, QC, F&E, and Supply Chain on all aspects of warehouse operations.

• Receive and organize daily deliveries of equipment and supplies.

• Perform GMP receipt of GMP materials into ERP, inspect, label, and store.

• Fulfill material requests generated by ERP and distribute to the requesting departments.

Manufacturing Support Operations:

• Stock, rotate, and inventory storage areas within the manufacturing facility.

• Stock personnel and gowning airlocks.

• Remove soiled gowning from the facility.

• Sanitize materials upon transfer into the manufacturing facility, receive and appropriately store.

• Collaborate with manufacturing personnel on material and restocking needs.

• Perform kitting operations.

General Responsibilities:

• Perform operations safely, as scheduled, and right the first time to ensure delivery of treatment to patients.

• Maintain gowning qualification to enter the controlled cleanrooms to perform job duties and support manufacturing activities.

• Complete and review GMP documentation in a timely manner.

• Maintain appropriate level of training for assigned responsibilities.

• Maintain all areas at a high standard of cleanliness and organization.

• Follow written procedures, GMP, and GDP requirements at all times.

• Interface with required systems to perform and document work, such as, ERP (Oracle), electronic batch records (PAS-X), and the Quality Management System (MasterControl).

• Perform physical cycle counts; reconciling with electronic inventory.

Qualifications:

• High school diploma and 2+ years of experience in GMP, GxP, or a regulated industry.

• Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).

• Experience with electronic systems such as MES and ERP.

• Military experience is highly sought after

• Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.

• The desire and ability to work in a fast-paced, start-up environment.

• Strong attention to detail.

• Experience in supply chain, warehouse, or manufacturing support operations.

• Experience with electronic systems such as MES and ERP.

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.