CaseBioscience is a quality-driven cGMP manufacturer and formulator of advanced media and biopreservation solutions to serve and advance the fields of cell therapy, gene therapy and regenerative medicines. Our mission is to serve as a reliable and timely strategic partner to support research, pre-clinical and clinical activities through our custom manufacturing services and our innovative culture medium and biopreservation solutions.
General Summary and Purpose
- The Quality Control Managers is responsible for implementing and managing CaseBioscience’s quality management system to ensure it conforms to the standards and regulatory requirements for our industry.
- You will be responsible for working with internal and external constituents to ensure CaseBioscience products meet the highest applicable standards and regulatory requirements.
- You will work under the Quality Management System (QMS) to ensure the delivery of safe and effective products through completion of investigation management, risk management, material management, vendor qualification, product disposition, validation approval, internal and external audits, etc.
- Perform technical quality control (QC) procedures as needed for the clinical laboratories.
Job Description Duties and Responsibilities:
- Performs procedures as required under the QMS.
- Perform incoming QC on specified raw materials.
- Perform release testing of applicable products.
- Perform environmental monitoring of classified spaces and complete/approve microbial investigations as needed.
- Assist in coordinating the transfer of products from development to manufacturing and QC as directed, including equipment qualifications and test method validations.
- Write and update procedures under the responsibility of QA and QC.
- Review and approval of complaint investigations.
- Review documents for approval as directed. These may include reports, batch records, validations, and others.
- Assist in internal and external assessments including writing assessment reports as needed.
- Complete vendor qualification and requalification per the procedure and as new suppliers are needed.
- Complete change control as needed for revised, retired, or new procedures as well as any other change requiring the form.
- Complete gowning qualification, as required.
· Perform and assist in the qualification of controlled, classified spaces.
- Help ensure the QC lab is maintained, including premises and equipment
- Education – BSc, MSc or PhD required preferably in a life-science related field, such as Biology, Molecular Biology, Microbiology, Immunology, Biochemistry, Biotechnology, or Engineering
- 1-2 Years Minimum previous sales experience
CaseBioscience is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.