Quality Specialist

About the role

We are actively hiring multiple Quality Specialists / Analysts to support a growing organization dedicated to advancing regenerative therapies and improving patient outcomes. This is an excellent opportunity for recent science graduates and early-career professionals with laboratory or regulated industry experience who are interested in transitioning into a highly visible Quality role. You will work closely with laboratory, manufacturing, and quality teams to help ensure products meet the highest standards of safety, compliance, and quality.

The Quality Specialist is responsible for supporting Quality Assurance and Quality Control activities for a regenerative medicine laboratory and manufacturing environment. This role is primarily desk-based and focuses on documentation review, investigations, CAPA management, deviation tracking, and compliance activities to ensure adherence to established regulations, procedures, and quality standards.

Responsibilities

• Review batch production records and manufacturing documentation as part of product lot release activities
• Coordinate and track Corrective and Preventive Actions (CAPAs), Non-Conformance Reports (NCRs), and deviation records, ensuring timely completion and follow-up
• Support investigations, root cause analysis, and problem-solving efforts related to quality events and process improvements
• Coordinate and track environmental monitoring (EM) programs and associated documentation
• Assist with the development, review, and release of environmental monitoring trend reports while escalating significant findings when appropriate
• Provide support and guidance related to batch release requirements and quality compliance processes
• Support Quality Management System (QMS) activities across current Good Manufacturing Practice (cGMP) departments
• Perform Quality Control activities, including incoming material inspections, in-process inspections, and finished product inspections
• Inspect medical devices, sterile processed human tissue-based products, raw materials, component supplies, and labeling materials for compliance with quality standards
• Maintain thorough and accurate documentation in accordance with Good Documentation Practices (GDP)
• Support gowning qualification programs and training activities
• Review and approve microbiology and environmental monitoring test results in a timely manner
• Collaborate with cross-functional teams to implement effective corrective and preventive actions for recurring quality concerns
• Assist with equipment qualification reviews, calibration documentation, and preventive maintenance activities
• Participate in regulatory inspections, customer audits, and internal audit activities as needed

Qualifications

Required

• Bachelor's degree in a scientific discipline such as Biology, Chemistry, Microbiology, Biochemistry, or a related field
• Minimum of 6 months of experience working in a regulated laboratory, manufacturing, quality, or other highly regulated environment

Preferred

• Experience working within biotechnology, pharmaceutical, medical device, tissue banking, or related life sciences industries
• Exposure to cGMP, Quality Systems, CAPAs, deviations, investigations, NCRs, or document control processes
• Experience reviewing technical documentation, laboratory records, or manufacturing records

Benefits

Why consider this opportunity:

• Join an innovative organization at the forefront of regenerative medicine and nerve regeneration
• Build valuable experience in Quality Assurance, Quality Systems, and regulatory compliance
• Gain exposure to investigations, CAPAs, deviations, audits, and cGMP operations
• Work cross-functionally with laboratory, manufacturing, and quality professionals
• Develop highly transferable skills that can accelerate long-term career growth within the biotechnology, pharmaceutical, and medical device industries

Pay range: $25.00 - $26.50/hr. Individual compensation within this range depends on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits (eligibility requirements apply and may depend on job classification and length of employment):

• Medical, dental & vision
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan with pre-tax and Roth post-tax contributions
• 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)

Location & schedule

Permanent, fully onsite position based in Dayton, OH. Application deadline: November 2, 2026.