- 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 audits
- Responsible 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.
- Bachelor's Degree in life science or a related scientific discipline, 5 to 10 years experience in Quality Assurance roles
- Working knowledge of cGMP principles with respect to FDA regulations
- Workable knowledge with aseptic processing regulations and guidelines
- Knowledge and experience with risk-based approach to Quality System implementation
- Previous 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 priorities
- Ability to work collaboratively with teams and collaborators
- Join a high-growth and fast-paced organization.
- Defined career path and annual performance review and feedback process.
- Comprehensive Benefits Plan, including 100% company-paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more
- Competitive company 401k match.
- Paid holidays, sick leave, and annual leave.
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Specialist, Quality Assurance, Cell Therapy - Rockville, United States - AbelZeta Inc
Description
Job Description
Job DescriptionAbelZeta is a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapy products. AbelZeta 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:
Qualifications and Requirements:
Why You Should Join AbelZeta
AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual's particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta's total compensation package for employees.
