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Quality Control Scientist II

3 months ago

Columbus, United States Actalent Full time

Job Title: Quality Control Scientist II

Job 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 SOPs, 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.

Requirements

  • BS in Biology, Chemistry, or a similar focus

  • 3+ years of GMP experience (this is a minimum qualification for a SCI II)

  • Clean room experience, pharma experience, or cell and gene therapy experience would all be an added bonus

Work Environment

This is a very team-oriented environment that works very closely with one another.

Team size is 6-8 and the dress code is business casual. 1st shift M-F 7am-4pm or 8am-5pm.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are Embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email (see below) (% (see below) ) for other accommodation options.