Quality Assurance Specialist
About the Company
Cellular Technology Limited (CTL), a VION Biosciences company headquartered in Cleveland, Ohio, is a global biotechnology company and the industry leader in the development, use, and manufacture of standardized immune monitoring tools for clinical and research applications. We offer meaningful work, competitive salaries, and opportunities for professional development and career advancement.
About the Role
We are seeking a dynamic Quality Assurance Specialist to join our growing Regulatory Affairs/Quality Assurance (RA/QA) Department. In this role, you will support and contribute to the Quality Management Systems, ensuring compliance with applicable laws, regulations, and standards. You will collaborate with employees to incorporate quality improvement initiatives under the supervision of the RA/QA Director.
Responsibilities
- Create, update, and maintain processes and procedures in collaboration with functional owners to ensure compliance with standards.
- Perform inspections of CRO-regulated studies.
- Lead Nonconformance, Complaint, Deviation, Change Management, Risk Management, and Corrective Action Preventive Action (CAPA) processes.
- Champion efforts to comply with all safety, quality, and operational documentation requirements and practices.
- Lead the auditing process to ensure compliance with ISO 9001 and other regulations and standards.
- Lead Supplier Qualification processes.
- Manage Quality Surveys and Questionnaires.
- Perform final quality inspections for the release of products.
- Monitor inspection, calibration, and maintenance processes.
Requirements
- Bachelor’s degree in a science-related or engineering-related scientific discipline.
- Minimum of 3 years’ quality assurance experience, preferably with technical knowledge and/or experience with GLP/GCP/GMP regulations and the Life Sciences product manufacturing industry.
- Minimum 3 years of experience with Quality Management Systems (ISO 9001, ISO 13485, FDA, and/or EU IVD regulations). Experience with CE/UL/RoHS & REACH is a plus.
- Strong analytical, problem-solving, and communication skills; ability to work in a fast-paced, regulated environment.
Benefits
- Comprehensive medical coverage.
- 401(k) with company match.
- Generous paid time off (PTO) and paid holidays.
- Life and disability insurance.
- Dental and vision options.
- Opportunities for professional development and career advancement.