URGENTLY HIRING: Quality Specialist I

Quality Specialist

We are actively hiring for multiple Quality Specialists within the regenerative medicine space here in Dayton, OH! These roles will primarily be desk based and performing documentation review, handling Corrective and Preventative Actions, performing investigations, handling deviations, and supporting other areas as needed. These are all supporting the lab and manufacturing to ensure they are continuing to follow necessary regulations and protocols. Candidates should have a Bachelors Degree in a Scientific discipline and at least 6 months of experience working in a regulated laboratory or similar environment. Candidates with a PhD level education will not be considered.

The Quality Specialist will be supporting a regenerative nerve and medicine laboratory by performing desk based document review, handling CAPAs, investigations, deviations, and performing other duties to ensure proper regulations and protocols are being followed.

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 all tasks are completed on time.
• 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.

Qualifications:

• Bachelors degree in a scientific discipline.
• Minimum of 6+ months of experience working in a heavily regulated industry.

Job Type & Location:

This is a Contract position based out of Vandalia, OH.

Pay and Benefits:

The pay range for this position is $25.00 - $26.50/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 Vandalia,OH.

Application Deadline:

This position is anticipated to close on Oct 18, 2026.