Quality Control Specialist

Weekend Shift

Saturday & Sunday 3:00 PM - 11:30 PM (10 or 12-hour shifts available, with additional hours during the week on 2nd shift)

Primary purpose

The Quality Control Specialist reviews manufacturing and post-processing records for acceptability and monitors environmental conditions to ensure compliance. This role is ideal for someone who thrives in fast-paced environments and remains organized while managing multiple tasks and competing demands.

Essential functions

• Audits manufacturing records and approves tissue grafts for release to distribution.
• Monitors processes and evaluate the need for preventive action.
• Initiates deviation documentation when appropriate and ensures appropriate notifications and tissue quarantine is completed.
• Performs inspection and review of tissue grafts/packaging, ensuring that all grafts released for processing, packaging, labeling and/or distribution meet all applicable regulations, standards, and customer specifications. Ensures proper disposition of all products.
• Performs environmental testing and follow-up.
• Recognizes and solves problems; assists the department with implementation of solutions.
• Monitors temperature-controlled equipment and investigates deviations.
• Assists in validation initiatives as needed.
• Actively participates in the implementation of corrective and preventive actions and performs effectiveness checks as needed.
• Track errors, identifies trends and assists in documents error investigations.

Minimum requirements

• High School Diploma or equivalent.

Work environment and physical activities

• Must be able to meet the required physical demands with or without reasonable accommodation.
• Periodic travel between the Dayton and Kettering Ohio facilities may be required.

Desired qualifications

• Experience in quality control, quality assurance, clinical laboratory, tissue banking, or pharmaceutical/other manufacturing environment.
• Technical and professional experience in analyzing process opportunities and developing and implementing strategies for improvement.
• Knowledge of applicable regulatory requirements from AABB, AATB, FDA, OSHA & ISO.
• Experience in auditing, quality control, quality assurance, clinical laboratory, blood/tissue banking, or pharmaceutical/other manufacturing environment.
• Sound knowledge and understanding of GMP & GTP requirements and industry standards.
• Proficiency in Microsoft Word and Excel programs.

We offer:

• A highly competitive benefits package including: medical, dental, vision, life and supplemental insurance.
• 401(k) with employer contribution and match.
• On-Demand Pay - Reduce financial stress with on-demand pay access to your earned pay.
• Generous paid time off (PTO) - up to 5 weeks in your first year!
• Opportunities to participate in recreational activities, join various employee committees and give back to the community.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or other characteristic protected by law. Drug Free Workplace

Public Service Loan Forgiveness Eligible Employer