Quality Control Scientist II

Description:

• The individual will work primarily in the Quality Department to support the testing and analysis of cGMP produced viral vectors and cells
• Works in close collaboration with the QC manager and senior QC staff to cultivate and enact strategic direction to the GMP area
• Under the guidance of senior staff, duties will include: performance of QC methods, development of methods, analysis of microbiological environmental monitoring samples, writing/revising SOP’s, equipment maintenance and monitoring, and materials management of QC and Production supplies.
• Help support Material Release process
• Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF.
• Ensure all product samples are adequately labelled and all aspects of sample allocation and transition are appropriately documented in the respective format and systems.
• Ensure full accountability for product as it is allocated across sample requirements and storage conditions.
• Evaluate processes associated with sample management to identify gaps and implement improvements.
• Ensure documentation is completed, reviewed, filed and archived according to Standard Operating Procedures (SOPs).
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
• Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
• Works under close supervision of senior staff and leadership.
• Functional working in diverse and collaborative team environment utilizing clear communication to deliver high productivity.
• Documentation of all activities performed according to SOPs.

Additional Skills & Qualifications:

-BS degree in Biology or other science field

- Must have 2+ years experience in a Quality Analyst Role

- Must have GMP Quality experience (Preferably from Cell/Gene Therapy, Pharma, or FDA regulated company)

-Highly Prefer experience from GMP manufacturing .

-Looking for people that understand the regulatory and documentation constraints in a GMP environment