What are the responsibilities and job description for the QC Scientist II position at Actalent?
Description:
- The individual will work primarily in the Quality Department to support the testing and analysis of cGMP produced cells
- Works in close collaboration with the QC manager and Lead QC staff to cultivate and enact strategic direction to the GMP area
- Under the guidance of Leadership 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 SOPs.
- Maintain compliance with applicable regulatory requirements
- 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.
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)
- Experience from GMP manufacturing .
- Understand the regulatory and documentation constraints in a GMP environment
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $26 - $28
