Sr Specialist, Quality Assurance - EHS

Job Description

A clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapy products. Operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the US. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer patients.

We are seeking a collaborative and highly motivated Senior Specialist/Specialist, Quality Assurance in Rockville, Maryland facility. The candidate will be involved in the development the Quality Management System, Environmental Health & Safety, Compliance oversight of GMP / GCP operations, and oversight the day-to-day quality operations. Specifically the Specialist will work with developed and developing quality systems designed to provide ample/robust quality oversite.

Responsibilities and Duties

Responsible for Environmental Health and Safety development and implementation. Collaboration and liaison with clinical operations to ensure the manufacturing facility can support clinical operations. Training and oversight of quality management system functions such as metric development, maintenance, and reporting. Responsible for the initiation, revision, distribution, and version control of documents following GDP requirements. Planning and executing internal and supplier auditsResponsible for chairing and otherwise running tier review board meetings. Assist in reviewing the documents, including manufacturing Production Records, testing record, and validation protocols and reports. Responsible for the management and control of critical materials and starting materials. Provide oversight and assist in the review/ audit of suppliers, internal audit systems including safety inspections, and training systems (onboarding and ongoing)Perform quality investigations of manufacturing Deviations, GMP and Quality System issues, non-conforming materials, and CAPA. Provide Quality Assurance support resolving material, environmental, facility, and equipment manufacturing issues. Participate in the management of day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities. Participate in the validation tasks and the internal audits of the quality management system. Review equipment and facility technical and investigation reports. Participated in quality on-site activities. Assist in reviewing proposed changes to systems, procedures, methods, and submissions to regulatory agencies. Perform other duties that may be assigned.

Qualifications and Requirements

Bachelor’s Degree in life science or a related scientific discipline, 5 to 10 years experience in Quality Assurance rolesWorking knowledge of cGMP principles with respect to FDA regulationsWorkable knowledge with aseptic processing regulations and guidelinesKnowledge and experience with risk-based approach to Quality System implementationPrevious experience working with clinical stage biological products such as antibodies, vaccines, cell therapy, or recombinant antibodies. Strong communication and coordination skills, good language skills and the ability to analyze and solve problems with a positive work attitude. Ability to work in a dynamic, fast paced environment with shifting prioritiesAbility to work collaboratively with teams and collaborators