Quality Control Technician Specialist Environmental, 1st Shift

MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with the medical, scientific, as well as organ and tissue donation communities.

Our goal is simple–do what's right for patients, surgeons, tissue donors, and their families through our guiding principles.

Gather, compile, analyze and implement appropriate actions on environmental data relating to the clean room areas, Process technicians, equipment, materials, packaging, QA technicians, and finished goods sterility results as per MTF procedures. Initiate nonconformance reports when data or sampling deviates from procedure. Responsible for environmental assessments and dispositions within the nonconformance system. Responsible for reporting release metrics to Quality Assurance Management and monitor department metrics and dashboards to facilitate predictable tissue flow at or ahead of scheduled release date. Responsible to keep management well informed regarding any potential delay in release. Responsible to summarize environmental and FG testing weekly, analyzing trends and determining appropriateness of release authorization. Responsible to perform all investigation for trends reaching alert and /or action levels. Responsible to perform Monthly trend analysis on organisms and analyzing the data.

• Responsible to review, compile and analyze environmental data including water results, viable testing, non-viable testing, organisms and trend data for the ISO controlled areas and other environmentally monitored areas.
• Responsible to assess acceptability of data for authorization of tissue releases on a weekly basis as per MTF procedure and applicable regulatory requirements.
• Perform trend analysis and issue reports on environmental testing. Perform investigations required for any alert or action levels reached during trend analysis.
• Responsible to initiate and investigate NCRs identified during QA review and perform actions in the NCR system as required for NCR closure.
• Responsible for the creation and updates to QA procedures following MTF Biologics change control process in compliance with applicable regulatory standards.
• Monitor and report release metrics to QA Management.
• Perform on-boarding training as well as training on new processes and/or process changes.
• Perform additional duties, as assigned.

MINIMUM QUALIFICATIONS

Education:  Associate's Degree

Years of Experience:  5 - 7 years

 Other:   1) Five years related experience in Quality, documentation review, or Laboratory testing.   

               2) Five years Quality Assurance experience in a GMP or FDA regulated industry.

Specialized Knowledge, Technical Skills, and Abilities:

• Microbiology or Biology knowledge.
• Expertise in the standards relating to the ISO.
• Clean room requirements and standards.
• Must be proficient in data entry, Microsoft Outlook, Word and Excel.
• Must exhibit attention to detail, critical thinking, and problem-solving and effective communication skills.

PREFERRED QUALIFICATIONS

Education:  Bachelor's Degree

Years of Experience:  2 - 3 years

Other:   Two years of microbiology or biology experience.

At MTF Biologics we provide comprehensive benefits and resources to support our employees physical, emotional, and financial health.

• 4 weeks Paid Time Off (PTO)
• Paid Holidays
• Medical, Dental,  Vision Insurance and Prescription Drug Insurance
• 401K plan with company match
• Short & Long Term Disability
• Life & Accidental Death Insurance
• Tuition Reimbursement
• Health Care/Dependent Care Flexible Spending Accounts
• Adoption Assistance
• Voluntary Benefits (e.g., Pet Insurance, Legal, home and auto insurance)
• Sword Health (at home Physical Therapy)