Quality Specialist I
Actalent
Quality Specialist I
The individual will work primarily in the Quality Control Laboratory to support the testing and analysis of cGMP produced viral vectors and cells. This role involves close collaboration with the QC manager and senior QC staff to cultivate and enact strategic direction in the GMP area.
Responsibilities
+ Run sample assays five nights a week.
+ Perform the 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, and write/revise SOPs.
+ Maintain and monitor equipment, manage materials of QC and production supplies.
+ Assist periodically with clean room facility cleaning and viral vector product manufacturing.
+ 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 sample allocation and transitions are documented.
+ Maintain accountability for products across sample requirements and storage conditions.
+ Identify gaps and implement improvements in processes associated with sample management.
+ Complete, review, file, and archive documentation according to Standard Operating Procedures (SOPs).
+ Ensure compliance with regulatory requirements for cellular and gene therapy products.
+ Perform tasks according to established policies, procedures, and techniques with training and working knowledge.
+ Work under close supervision of senior staff and leadership in a diverse and collaborative team environment.
+ Document all activities performed according to GMP, cGMP, GLP, and QC standards.
Essential Skills
+ BS degree in Biology or other science field.
+ Experience in aseptic technique, mammalian cell culture, PCR, and ELISA procedures.
+ Understanding of regulatory and documentation constraints in a GMP environment.
Pay and Benefits
The pay range for this position is $24.00 - $24.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• 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 is anticipated to close on Sep 3, 2025.
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.
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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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