Laboratory Quality Analyst
About The Position
We are immediately hiring for a Quality Analyst here in the Dayton, Ohio area! This position is going to help support a laboratory team that focuses on manufacturing and processing for nerve regeneration for patients. This is a long-term career opportunity for someone looking to grow in the sciences! Candidates must have a Bachelors Degree in a scientific field and at least 6 months of industry experience. The Quality Analyst is primarily responsible for document review to ensure compliance with FDA and other necessary regulations.
Requirements
- Must have a Bachelors Degree in a Scientific field and at least 6 months of industry experience.
- May consider candidates with an Associates Degree in a scientific field and additional, relevant industry experience.
Responsibilities
- Review batch production and manufacturing records as part of lot release activities.
- Coordinate and track CAPA, NCR, and Deviation records, ensuring timely completion.
- Manage the site environmental monitoring (EM) testing program.
- Assist teams in problem-solving and root cause analysis for quality events.
- Provide input based on experience with batch release requirements.
- Conduct Quality Control activities including incoming material, in-process, and finished product inspections for medical devices and human tissue-based products.
- Maintain accurate records of Quality Control activities, adhering to Good Documentation Practices.
- Support gowning qualification and training.
- Ensure timely issuance, review, and approval of Microbiology and EM testing results.
- Implement corrective and preventive actions for recurring product/process discrepancies.
- Assist in hosting onsite regulatory audits and inspections.
Benefits
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Administrative and Support Services
Number of Employees
1,001-5,000 employees
