Regulatory Quality Specialist

About the role

We are actively hiring for multiple Quality Specialists within the regenerative medicine space in Dayton, OH. These desk‑based roles involve documentation review, handling Corrective and Preventive Actions (CAPAs), investigations, deviations, and supporting lab and manufacturing activities to ensure compliance with regulations and protocols.

Responsibilities

• Perform reviews of batch production records and manufacturing records as part of lot release activities.
• Coordinate and track Corrective and Preventive Action (CAPA), Non‑Conforming Report (NCR), and Deviation records, ensuring timely completion.
• Coordinate and track the site environmental monitoring (EM) testing program.
• Assist teams in coordinating problem solving and root cause analysis for quality events.
• Ensure the development, review, and release of quarterly environmental monitoring trending reports and promptly escalate significant trends to management.
• Provide input based on knowledge and experience with batch release requirements.
• Provide Quality Management System (QMS) operations support to all current Good Manufacturing Practice (CGMP) departments.
• Perform Quality Control activities at processing or distribution sites, including incoming material inspections, in‑process inspections, and finished product inspections.
• Inspect a range of products including medical devices, sterile processed human tissue‑based products, unprocessed human tissue, component supplies, and labeling materials.
• Maintain accurate and complete records of Quality Control activities in accordance with Good Documentation Practices (GDP).
• Provide support related to gowning qualification and training.
• Ensure timely issuance, review, and approval of microbiology and environmental monitoring testing results.
• Interface with colleagues to ensure effective corrective and preventive actions are implemented for recurring product or process discrepancies.
• Assist in the review and approval of equipment qualifications.
• Assist in the review of calibration and preventive maintenance activities.
• Assist in hosting onsite regulatory audits and inspections.

Requirements

• Bachelor’s degree in a scientific discipline.
• Minimum of 6 months of experience working in a heavily regulated laboratory or similar environment.
• Candidates with a PhD level education will not be considered.

Benefits

• 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 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)

Pay

The pay range for this position is $25.00 – $26.50 per hour. Individual compensation within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other job‑related factors.