Job Title - Quality Assurance Specialist III
Location - Frederick, MD
100% Onsite
Everyone at Client is grounded by one common goal curing cancer. Every single day, we seek to establish a line between that purpose and our day-to-day work.
Client, a Client Company, is a biopharmaceutical company focused on the development and commercialization of Client cancer immunotherapy products designed to harness the impactfulness of a patients own immune system to selectively target cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team motivating to new frontiers of care for cancer patients.
We are seeking a highly motivated individual to join us as QA Specialist III at our commercial manufacturing site (currently under construction) in Frederick, MD. In this position, you will provide Quality Assurance oversight of Commercial Manufacturing, Materials Management, and Quality Control areas. Must be proficient in Quality Systems, particularly associated with Operations, Lot Disposition, Change Control and Exception Management / CAPA.
Responsibilities include (but are not limited to):
Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
Coordinate and facilitate Quality Assurance related production and production related activities, including:
o Assessment and closure of discrepancies, deviations and change controls requests.
o On-the-floor support Quality support to manufacturing and QC staff.
o Assessment and closure of laboratory investigations.
o Timely assessment and closure of batch and material hold events.
o Review of batch manufacturing and testing documentation for timely delivery of final product.
Ensure that tests are performed, and products are manufactured in compliance with Client specifications, regulatory and GMP guidelines.
Compile and verify all batch related documents into a final product lot disposition package.
Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA.
o Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
o Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities.
o Provide periodic updates to stakeholders for deviations, GMP and system issues, non-conforming materials and products and CAPA.
Perform other duties as required.
Basic Qualifications:
Masters Degree and 3+ years experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR
Bachelors Degree and 5+ years experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR
High School Degree and 9+ years experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
Preferred Qualifications:
Proficient in Quality Systems, particularly associated with Operations, Lot Disposition and Exception Management/CAPA.
Thorough knowledge of GMP, SOPs and quality systems.
Ability to effectively negotiate and develop collaboration amongst individuals.
Excellent interpersonal, verbal and written communication skills.
Experience with laboratory investigations, deviations, and CAPA.
Experience with change control practices and strategies.
General knowledge of aseptic manufacturing processes.
Proficient in MS Word, Excel, Power Point and other applications.
Ability to communicate and work independently with scientific/technical personnel.
Comfortable in a exciting small company environment with minimal direction and able to adjust workload based on changing priorities.