Quality Specialist II

Job Overview

This role is the first line of defense for the quality labs in the CMF, providing guidance, reviewing batch records, and determining whether discrepancies can be remedied or need escalation to the investigations team.

• 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.
• 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 for cellular and gene therapy products.
• Perform in accordance with established policies, procedures, and techniques requiring training and experience related to the tasks performed.
• Work under close supervision of senior staff and leadership.
• Function within a diverse and collaborative team environment utilizing clear communication to deliver high productivity.
• Document all activities performed according to SOPs.

• BS degree in Biology or another science field.
• Experience in a highly regulated environment with strong documentation practices.
• Experience in a GMP environment preferred; other highly regulated environments such as GLP are also acceptable.

Contract to Hire position based in Columbus, OH.

Pay: $28.00/hr.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital coverage
• 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)

Fully onsite in Columbus, OH.

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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.

San Francisco Fair Chance Ordinance:
For all positions located in the city and county of San Francisco, we will consider qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team.