Title: QC Analytical Associate III
Salary: $90,000 - Full Time
Summary: Our client is a global leader in cell and gene therapy manufacturing who is dedicated to the field of regenerative medicine. They have worked with both autologous and allogeneic cell therapies and believe in the revolutionary potential of cell and gene treatments. They provide opportunities in the gene therapy sector for people seeking to revolutionize medicine while continually enhancing a cutting-edge, expanding business.
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:
- Performs all company and/or client test methodologies and procedures for cellular items accurately to ensure the protection and/or effectiveness of various cell populations.
- Maintains training records and collaborates with the Document Control and Training groups on record retention.
- Under direct supervision, performs state proficiency testing and/or client proficiency testing as applicable.
- Performs and facilitates with equipment and method qualification and validation as necessary.
- Creates and carries out corrective and preventative measures as necessary.
- Records the instruction given and the actual shipping of test samples to outside laboratories for analysis.
- Drives the management and resolution of quality issues with clients, partners, and internal staff.
- In consultation with important stakeholders and in accordance with company policies, makes knowledgeable and independent decisions on complex issues.
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 industrial experience in cell count methodologies preferred
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 - Experience working with flow cytometry
Benefits and Perks:
- Medical
- Dental
- Vision
- 401K matching
