Quality Control Specialist I

INTERESTED CANDIDATES CAN SEND UPDATED RESUMES TO: JGASSER @ ACTALENTSERVICES.COM

OR TEXT JENNA TO SETUP A PHONE CALL: 419. 980. 5823

DESCRIPTION:

The individual will work primarily in the Quality Control Laboratory to support the testing and analysis of cGMP produced viral vectors and cells. The position involves close collaboration with the QC manager and senior QC staff to cultivate and enact strategic direction in the GMP area. Responsibilities include performing sample assays, operating and maintaining QC lab equipment, and supporting the development of QC methods.

RESPONSIBILITIES:

Perform proper operation, calibration, validation, cleaning, and maintenance of QC lab equipment.Under the guidance of senior staff, perform QC methods, develop methods, analyze microbiological environmental monitoring samples, write/revise SOPs, and manage QC and Production supplies.Assist periodically with the cleaning of the clean room facility and manufacturing of viral vector products.Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF.Ensure all product samples are adequately labeled and all aspects of sample allocation and transition are appropriately documented.Maintain full accountability for product allocation 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 for cellular and gene therapy products.Perform tasks in accordance with established policies, procedures, and techniques, requiring training and working knowledge related to the tasks performed.Work under close supervision of staff and leadership.Function effectively in a diverse and collaborative team environment utilizing clear communication to deliver high productivity.

Essential Skills

BS degree in Biology or other science field.Experience with aseptic technique, mammalian cell culture, PCR, and ELISA procedures.Understanding of the regulatory and documentation constraints in a GMP environment.

Pay and Benefits

The pay range for this position is $24.00 - $24.00

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Columbus,OH.

Application Deadline

This position will be accepting applications until Dec 27, 2024.

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 actalentaccommodation@actalentservices.com for other accommodation options.