(Sr.) Specialist, Quality Assurance

AbelZeta is a biopharmaceutical company focused on the development of novel cancer immunotherapy products. We operate 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 Specialist or Senior Specialist of Quality Assurance in Rockville, Maryland. The candidate will be involved in the development the Quality Management System and oversight the day-to-day quality operations.

Responsibilities and Duties:

• Responsible for the initiation, revision, distribution, and version control of documents and labels following GDP requirements.
• Responsible for performing Quality Assurance review of batch related documentation including batch records, COAs, test records, etc. and preparation of batch documentation.
• Responsible for tracking the chain-of-custody and chain-of-identity for batches
• Provide Quality Assurance oversight for QC activities including stability, method qualifications, OOS, aborted and invalid assays, in-process, and final product testing etc.
• Provide Quality Assurance support for the technical release of clinical batches.
• Responsible for the management, control and release of critical materials and starting materials.
• Perform quality investigations of manufacturing Deviations, GMP and Quality System issues, non-conforming materials, change requests, and CAPA
• Provide Quality Assurance support resolving material, in-process product, final product, 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 related to product
• Provide Quality Assurance support for on-boarding of new projects
• Participate in the management of raw material (receipt, storage and release)
• Participated in quality on site activities.
• Perform other duties that may be assigned.

Qualifications and Requirements:

• Bachelor’s Degree in life science or a related scientific discipline, 1-3 years’ experience in Quality Assurance roles
• Working knowledge of cGMP principles with respect to FDA regulations
• Workable knowledge with aseptic processing regulations and guidelines
• Sufficient knowledge of phase appropriate Quality System implementation and maintenance
• Knowledge and experience with risk-based approach to Quality System implementation
• Previous experience working with clinical stage biological products such as antibodies, vaccines 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

Preferred Qualifications:

• Self-starter with superior analysis and problem-solving skills ranging from simple to sophisticated situations.
• Be proficient in MS Office suite.
• Demonstrates proficiency in current Good Manufacturing Practices (GMPs).
• Possess good communications skills to explain information and influence others
• Must have a strong work ethic and demonstrate dependability and timeliness.
• Have a high energy level and a positive outlook coupled with the requisite “can do” attitude.

Why You Should Join AbelZeta

• 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.

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.