Quality Assurance Analyst, 1st Shift

Overview

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.

 

Ensure that the documentation review performed for the release of tissue and medical devices is according to current MTF procedures and in compliance with applicable regulatory requirements.

 

Shecdule: Monday-Friday 8:15am-4:30pm

 

Salary Range: $62,000-$68,000/yr. 

Responsibilities

• Review release criteria in accordance with current finished good (FG) specifications, in-process finished goods (IFG) specifications, MTF procedures for tissue and medical devices, and applicable regulatory requirements.
• Identify deviations, discrepancies, or non-conformances associated with the work order. Notify the appropriate individuals, complete the necessary documentation, and ensure the deviations, discrepancies, or non-conformances have been resolved before the tissue or medical device units are released.
• Responsible for initiation, containment, and completing other action items assigned of non-conformances.
• Review non-conformances, problem statements, investigations, root cause analysis and risk assessments, and other applicable action items for closure of non-conformances.
• Print testing result reports from outside laboratories and internal MTF laboratories for review and incorporation into the processing record, if applicable.
• Complete appropriate documentation for the rejection of tissue and medical devices when required.
• Review recorded measurements for tissue and medical devices in accordance with current FG specifications and MTF procedures.
• Review packaging and labeling documentation for tissue and medical devices in accordance with current FG specifications, MTF procedures, and applicable regulatory requirements.
• Review tissue and medical device processing and storage documentation in accordance with current MTF procedures and applicable regulatory requirements.
• Interact with all departments to organize, review, and analyze all data pertaining to the release of tissue or medical devices for compliance with current MTF Procedures, IFG and FG specifications, and applicable regulatory requirements.
• Release tissue and medical devices to Inventory Control for international and domestic distribution.
• Review rework work orders and ensure the accurate destruction of tissue, if required.
• Enter all required data into the Quality Donor Data System (QDDS) and perform appropriate actions in QAD following review of tissue or medical devices.
• Perform additional duties, as assigned. 

Qualifications

• Associate's Degree or equivalent combination of education and/or work experience
• 1 year Experience in a GMP or FDA regulated industry.
• 3 years Document review or laboratory testing
• Strong written and verbal communication skills
• Must be proficient in data entry, Microsoft Outlook, Word, and Excel
• Must exhibit attention to detail, critical thinking, problem-solving and effective communication.

 

 

 

 

Benefits Information

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)