Description :
Overview:
The Quality Control Manager manages quality control services to the cord blood processing operations. Quality control services includes a team of 8 employees responsible for raw material testing and release, general blood banking and hematology testing, hematopoietic progenitor cell functional testing, and verification of proper cell freezing and storage conditions. These activities are performed in compliance with industry regulations, site operating procedures, quality and safety policies and cost and processing time standards.
Requirements:
Education: BS degree in Microbiology, Cell Biology, Molecular Biology, Biochemistry, Medical Technology or related science preferred.
Experience: Minimum of three years in a supervisory or management role overseeing a Quality Control function in a biotherapeutic manufacturing or clinical setting. Experience leading qualification, validation or continuous improvement teams.
Additional Requirements:
* ASCP registered preferred
* Experience in the development of validation procedures and maintenance of quality systems
* Experience with GMP, CLIA, and/or AABB regulations for laboratory testing
* Oversee all testing performed by the QC department
* Maintain a staffing schedule that ensures full coverage for daily testing volumes
* Strict attention to detail
* Ability to work in a collaborative style
* Conflict management skills
* Outstanding work ethic
* Ability to troubleshoot processing problems
* Ability to professionally respond to quickly changing priorities
* Hands on experience with testing instrumentation
* Analytical skills, including math and critical thinking
* Ability to develop and maintain a strong quality team
* Excellent communication skills across all organizational levels
* Interact with Quality Assurance, Regulatory and Research and Scientific functions to evaluate and integrate testing methodologies into QC
* Develop, manage, communicate and execute quality plans and goals for projects