Title: QC Analytical Associate III
Our client's goal is to work together to produce future cell therapy miracles. We are a leading firm that specializes in cell and gene therapy product research and manufacture on a global scale. We are influencing the future of medicine because we think that cell and gene treatments have the power to revolutionize health care. We provide opportunities in the regenerative medicine market for people seeking to revolutionize medicine while continually enhancing a cutting-edge, expanding business. This position will report into the Supervisor of QC Microbiology
The Quality Control Analytical Associate III plays a supporting role in both clinical and industrial production. To guarantee that quality standards are kept for all goods produced at the plant, the QC Analytical Associate III will aid with process check points, stability testing, and release analytical testing.
Function and Responsibility:
Under the direction of the Manager, QC Analytical, responsibilities of the QC Analytical Associate III will include but are not limited to:
- Accurately executes all test methodologies and procedures for cellular goods used by the company and/or clients to assure the safety and/or effectiveness of various cell populations.
- Keeps track of training records and works with the Document Control and Training units to determine how long to keep records.
- Performs state proficiency testing and/or client proficiency testing, as necessary, under direct supervision.
- As required, performs and assists with equipment and method qualification and validation.
- Develops and implements appropriate remedial and preventative measures.
- Keep track of the guidance provided and the delivery of test samples to outside laboratories for examination.
- Encourages clients, partners, and internal staff to work together to manage and resolve quality issues.
- Makes informed, impartial choices on complicated issues after consulting with significant stakeholders and in compliance with corporate policy.
Qualifications and Requirements:
- BA/BS in a science or relevant field required
- MS is preferred
- Prior cGMP experience required
- Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must
- Prior academic and/or industrial cell therapeutic experience preferred
- Minimum 4-6 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry
- Need experience working with flow cytometry
Benefits and Perks:
- 401K matching