Quality Assurance Specialist

Quality Assurance Specialist

The Specialist Manufacturing is responsible for executing processes related to deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR / EN), and Change Control quality records. This role serves as the External Supply representative across functional teams to ensure the timely closure of quality records. The position manages quality records originating from manufacturing sites and acts as the main point of contact for the New Albany, OH site.

Responsibilities include addressing and closing quality records such as Deviations, CAPAs, CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations, and Change Control under the company's quality management system procedures. Ensure compliance with regulatory agency requirements, monitor and investigate deviations owned by External Supply and implement corrective / preventive actions. Partner cross-functionally to ensure the maturity and execution of robust Deviations / CAPA processes. Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management. Collaborate with site and technical teams to evaluate observed supplier-related defects.

Essential Skills include Quality assurance, GMP, Quality control, Batch record management, CAPA, FDA compliance, Audit, Batch record review, Strong communication, Reliability, Critical thinking.

Additional Skills & Qualifications include a Master's or Bachelor's degree in a Science-related field preferred, experience with quality records, including CAPA and Change Control, familiarity with Veeva or TrackWise systems, prior experience in pharma, biotech, or medical device industries preferred, basic project management skills, 3-5 years of hands-on experience managing deviations, change controls, and CAPAs, strong grasp of root cause analysis and investigation review, ability to operate in a fast-paced remote environment, and associate degree holders with 10 years of deep experience will be considered.

Work in a brand new, FDA / GMP-regulated facility that is very automated and high-tech. The environment is designed to support fast-paced and efficient work processes.

This is a Contract position based out of New Albany, Ohio. The pay range for this position is $28.00 - $35.00 / 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).

This is a hybrid position in New Albany, OH. This position is anticipated to close on Oct 23, 2025.