Quality Control Technician Specialist Environmental, 1st Shift

Musculoskeletal Transplant Foundation; Edison, Orange City (NJ, FL); On-site; USD 70,000 - 90,000; Full time

Job summary

A nonprofit organization dedicated to saving and healing lives is seeking a Quality Assurance professional. The role involves analyzing environmental data, ensuring compliance with ISO standards, and managing quality metrics. Candidates should have a strong background in microbiology or biology, with significant experience in quality assurance within a regulated industry. Comprehensive benefits include PTO, health insurance, and retirement plans.

Benefits

4 weeks PTO

Paid Holidays

Medical, Dental, Vision, Prescription Insurance

401K with match

Disability Insurance

Life & Accidental Death Insurance

Tuition Reimbursement

Flexible Spending Accounts

Adoption Assistance

Voluntary Benefits

Sword Health Physical Therapy

Qualifications

• 5-7 years in quality, documentation review, or laboratory testing.
• 5 years QA experience in GMP or FDA-regulated industry.

Responsibilities

• Gather and analyze environmental data for clean room areas.
• Initiate nonconformance reports and conduct environmental assessments.
• Monitor department metrics and ensure predictable tissue flow.

Skills

Microbiology

Biology

Attention to detail

Critical thinking

Problem-solving

Effective communication

Education

Associate's Degree

Bachelor's Degree

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Job description

Overview

MTF Biologics processes tissue grafts from human donors used in various clinical applications, positively impacting lives worldwide. As a nonprofit organization dedicated to saving and healing lives, we collaborate with medical, scientific, and donation communities.

Our goal is to prioritize what’s right for patients, surgeons, donors, and their families, guided by our principles.

Responsibilities include gathering, analyzing, and implementing actions on environmental data related to clean room areas, process technicians, equipment, materials, packaging, QA technicians, and finished goods sterility results, following MTF procedures. Initiate nonconformance reports for deviations, conduct environmental assessments, and manage dispositions within the nonconformance system. Report release metrics to QA Management, monitor department metrics, and ensure predictable tissue flow. Keep management informed of potential delays. Summarize weekly environmental and finished goods testing, analyze trends, and determine release appropriateness. Investigate trends reaching alert or action levels. Perform monthly organism trend analyses.

Responsibilities

• Review, compile, and analyze environmental data including water results, viable and non-viable testing, organisms, and trend data in ISO-controlled and monitored areas.
• Assess data acceptability weekly for tissue release authorization per MTF procedures and regulations.
• Perform trend analyses, generate reports, and investigate alert/action level events.
• Initiate and investigate NCRs during QA reviews, closing them as required.
• Create and update QA procedures following change control processes and regulatory standards.
• Monitor and report release metrics to QA Management.
• Conduct onboarding and process change training.
• Perform additional duties as assigned.

Qualifications

Minimum Qualifications

Education: Associate's Degree

Experience: 5-7 years in quality, documentation review, or laboratory testing; 5 years QA experience in GMP or FDA-regulated industry.

Skills:

• Microbiology or Biology knowledge
• Understanding of ISO standards
• Knowledge of clean room standards
• Proficiency in data entry, Microsoft Outlook, Word, Excel
• Attention to detail, critical thinking, problem-solving, effective communication

Preferred Qualifications

Education: Bachelor's Degree

Experience: 2-3 years microbiology or biology

Skills: Additional microbiology or biology experience preferred.

Benefits

We offer comprehensive benefits supporting physical, emotional, and financial health:

• 4 weeks PTO
• Paid Holidays
• Medical, Dental, Vision, Prescription Insurance
• 401K with match
• Disability Insurance
• Life & Accidental Death Insurance
• Tuition Reimbursement
• Flexible Spending Accounts
• Adoption Assistance
• Voluntary Benefits
• Sword Health Physical Therapy