Quality Assurance Specialist — Regenerative Medicine

Actalent; Dayton (OH); On-site; USD 34,000 - 37,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Paid time off

Job summary

Actalent is hiring multiple Quality Specialists/Analysts for a regenerative medicine environment in Dayton, OH. The role focuses on documentation review, investigations, CAPA management, and compliance across QA/QC activities to ensure products meet safety and quality standards.

This desk-based position supports batch release, QMS activities, and cross-functional collaboration with lab, manufacturing, and quality teams. 6 months of regulated industry experience is preferred.

Qualifications

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

Responsibilities

• Review batch production records and manufacturing documentation for lot release.
• Coordinate and track CAPAs, NCRs, and deviation records with timely closure.
• Support investigations, root cause analysis, and problem-solving for quality events.
• Coordinate environmental monitoring programs and related documentation.
• Assist with development, review, and release of environmental monitoring trend reports.

Skills

Quality Assurance

Quality Systems

Investigations

CAPA management

Documentation review

cGMP

Education

Bachelor's degree in Biology/ Chemistry/ Microbiology/ Biochemistry or related field

Job description

Actalent is hiring multiple Quality Specialists/Analysts for a regenerative medicine environment in Dayton, OH. The role focuses on documentation review, investigations, CAPA management, and compliance across QA/QC activities to ensure products meet safety and quality standards.

This desk-based position supports batch release, QMS activities, and cross-functional collaboration with lab, manufacturing, and quality teams. 6 months of regulated industry experience is preferred.