Quality Specialist II

Quality Specialist II

Join a dynamic team that serves as the first line of defense for quality assurance in a rapidly growing, state-of-the-art facility. Although this role is not lab-based, it plays a crucial part in providing guidance, reviewing batch records, and determining the course of action for discrepancies. You will operate within the Quality Management System to ensure compliance and accuracy in the manufacture of phase-appropriate materials.

Responsibilities

• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material.
• Ensure all product samples are adequately labeled and document all aspects of sample allocation and transition.
• 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 Standard Operating Procedures (SOPs).
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
• Perform tasks in accordance with established policies, procedures, and techniques under the supervision of staff.
• Collaborate effectively within a diverse and cross-functional team environment.
• Document all activities performed according to GMP, cGMP, GLP, QC, and other relevant standards.

Essential Skills

• Bachelor's degree in Biology or related science field.
• Experience in a highly regulated environment with strong documentation practices.
• Preferred experience in a GMP environment, but experience from other regulated environments such as GLP is also considered.

Additional Skills & Qualifications

• Technical writing skills.
• Experience with investigations and CAPAs.
• Ability to work under supervision and follow established procedures.

Work Environment

Work primarily at a desk with cleanroom visits about twice a week. Collaborate within a team of 9-10 people in a rapidly growing company building new sites in Columbus, Ohio. The facility features state-of-the-art clean rooms and equipment. The role is almost entirely onsite with flexible hours between 8am-5pm, allowing for personal commitments. Weekend work is on a voluntary basis to address backlog.

Job Type & Location

This is a Contract to Hire position based out of Columbus, Ohio.

Pay and Benefits

The pay range for this position is $28.00 - $28.00/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 Oct 3, 2025.