Sr. QA Compliance Specialist

at  CARsgen Therapeutics Corpora

TOGETHER, WE MAKE CANCER CURABLE

Led by an experienced management team of academic professionals and industry veterans, we have built an integrated cell therapy platform with in-house capabilities that span from target discovery, lead antibody development, clinical studies to commercial-scale manufacturing. Our vision is to become a leading biopharmaceutical company developing globally revolutionary cell therapies to make cancer curable. If you are looking for an opportunity with an innovative and solidly growing company, join us.

QUALIFICATIONS

• Degree in Biology, Microbiology, Biochemistry, or other life sciences from an accredited university or college
• 8+ years of experience in QA or GMP environment or equivalent.
• Working experience in Biotechnology is highly desired, but working experience in pharmaceuticals is a must.
• Strong working knowledge of GMP Regulations and ICH Guidelines governing current Good Manufacturing Practices for Pharmaceuticals and Biotechnologies. Excellent cGMP documentation skills
• Experience authoring investigations for manufacturing, process, and laboratory out of specification.
• Ability to conduct in-depth interviews and gather pertinent information to drive to root cause conclusions, product impact analyses and initiations of CAPA actions, if required
• Exceptional technical writing and communication skills to clearly convey investigational findings
• Detail oriented, self-motivated and a team player with the ability to handle multiple tasks
• Must be comfortable in a fast-paced environment with minimal supervision and flexibility of changing priorities.
• Growth-oriented with a continuous improvement mindset, and passionate about working with others in a complex manufacturing environment.

• Create, revise, implement, and support quality assurance standard operation procedures for the site.
• Support the Quality Systems team with emphasis on the QA oversight of the following processes: calibrations, preventive maintenance, material control, training, and CAPAs.
• Conduct data analysis to support tracking of Key Quality Performance Indicators and generate the quality metrics monthly reports.
• Identify opportunities to increase the efficiency and effectiveness of the QMS.
• Support internal audits and assist in regulatory inspections (e.g., prep room participant, scribe)
• Support site training activities including developing training materials and providing training for new employees.
• Maintain updated knowledge and relevant assessments of the GxP landscape, regulations, and guidelines pertaining to Quality Systems.
• Represent the Quality System in cross-functional projects where applicable, such as QMS improvements, implementation of an electronic solution for tracking and approving calibrations and PMs, and assigning material codes.
• Assist in the support of compliance oversight of materials management for the site.
• Drives continuous improvement efforts regarding Quality Management System processes by identifying improvement opportunities and presenting solutions to the improvement opportunities.
• Support the Quality System as part of the quality and compliance objectives with emphasis on the following processes: Deviation, Change Control, Out of Specification, Out of Trend, and CAPA.
• Review investigations related to GMP cell product manufacturing (manufacturing, QC, QA, material management, facility, IT); works cross-functionally during investigations to determine root cause and potential preventative/corrective actions. Ensure investigations will withstand regulatory scrutiny and are compliant with cGMP regulations.
• Responsible for the timely closure of investigations and quality records to support quality metrics, on-time batch release, and patient first mentality.
• Proactively track deviation/change control/CAPA status to ensure batch release process is not impacted by outstanding deviations.
• Author or approve change control related to GMP activities.
• Maintain updated knowledge and relevant assessments of the GxP landscape, regulations, and guidelines pertaining to Quality Systems.
• Drives continuous improvement efforts regarding Quality Management System processes by identifying improvement opportunities and presenting solutions to the improvement opportunities.
• Perform any other tasks/duties as assigned by Management.