Quality Specialist II - Batch Review

We are looking to add a Quality Specialist II with a large Gene Therapy company in the area!

This team serves as the first line of defense for whenever there's any issues in the suite/lab and some guidance might be needed.

This role handles all quality documentation and concerns before determining if an issue might need to be escalated to the Investigations team.

This role does not perform any laboratory testing, and focuses more on the documentation side of thigns.

An ideal candidate will have a Bachelors in a science and at least 2-3+ years of experience working in a heavily regulated quality laboratory or documentation environment.

Experience can come from GMP, GLP, FDA, or other similarly regulated environments (typically anything in food or pharma would qualify). This is a 1st shift opportunity.

Description: This is the largest part of the quality team and provides the first line of defense whenever any issues pop up in the laboratory.

This role may involve going into the cleanroom about twice a week, but does not perform any laboratory testing.

Job duties will primarily include: * Reviewing any discrepancies to see if they can be remedied, or if they need to be escalated.

* Review batch records.

* Oversee and assist with any guidance needed in the cleanroom.

* Perform various quality documentation.

* Review quality documentation to ensure it meets necessary regulations and guidelines.

Qualifications: * Must have a Bachelors Degree (preferably in a scientific field) * Must have at least 2-3+ years of experience working in the quality department in a heavily regulated environment (GMP preferred, but would also consider GLP, FDA, or other similarly regulated environments). 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 6, 2025.

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