Quality Assurance Specialist

Department of Regulatory Affairs & Quality Assurance

Company Profile:

Cellular Technology Limited (CTL), a VION Biosciences company headquartered in Cleveland, Ohio, is a global biotechnology company with locations and distributors worldwide. We are the industry leader in the development, use, and manufacture of standardized immune monitoring tools used in clinical and research applications. We are committed to offering meaningful work, competitive salaries, a full range of benefits, including comprehensive medical coverage, 401(k) with company match, generous paid time off (PTO), paid holidays, life and disability insurance, dental and vision options, and the opportunity for professional development and career advancement. CTL is fully committed to Equal Employment Opportunity without regard to race, sex, color, religion, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status.

Position Description:

We are seeking a dynamic Quality Assurance Specialist to join our growing Regulatory Affairs/Quality Assurance (RA/QA) Department. As the Quality Assurance Specialist, you will support and contribute to the Quality Management Systems, apply the requirements to processes, products, or services at CTL to help ensure compliance with applicable laws, regulations, and standards. The Quality Assurance Specialist will work collaboratively and cohesively with employees to incorporate quality improvement initiatives.

Under the supervision of the Regulatory Affairs/Quality Assurance (RA/QA) Director, you will:

• 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 in the auditing process to ensure compliance with ISO 9001 as well as other regulations and standards
• Lead Supplier Qualification processes
• Manage Quality Surveys and Questionnaires
• Perform final quality inspections for release of products
• Monitor inspection, calibration, and maintenance processes

Position Qualifications:

• Bachelor’s degree in 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 as well as experience in 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

Interested applicants should email a resume to: View email address on click.appcast.io