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, kitting, 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 AND 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.

　　Additional Skills & Qualifications:

　　PREFERRED EDUCATION & EXPERIENCE:

　　• 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.

　　KNOWLEDGE, SKILLS AND ABILITIES:

　　• 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.

　　PHYSICAL REQUIREMENTS:

　　The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:

　　• Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.

　　• Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns.

　　SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE*:

　　Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.

　　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

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.