Overview/Risks

                                   

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.

 

The Lead Technical Specialist is responsible to identify improvement opportunities and compliance enhancements in the QA analyst department by conducting audits and analyzing trends. Update documents and ensure that the procedures meet all regulatory requirements while maintaining MTF Values. Responsible for the training and all on boarding for all QA Analysts. Is fully competent and is the back up for the environmental reviews and release gates reviews in both Edison and Jessup. Is fully conversant and a SME on all relevant QA Analyst software and investigates non-conformances and CAPAs for QA Analyst Team. Provides support to the CAPA process for MTF as the QA subject matter expert Initiates and attends interdepartmental meetings to provide QA Analyst representation, decisions and positions. Assist the QA records management analyst with all file room activities, as needed. Perform IFG, 1st Review, 2nd Review and Verification of charts, as needed. Responsible for reporting daily release numbers to Quality Assurance Management.

 

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

Responsibilities

Ensure audit readiness for the QA Analysts and support internal/ external audits, including FDA, TGA, and Notified Body Inspections.

Collaborate with QE, R&D and PE to develop and revise QA procedures necessary to ensure FDA, ISO, TGA, and Canadian compliance.

Perform training to QA Analysts on new processes and/or process changes.

Perform the environmental review process, as required

Responsible for initiating and investigating NCRs affecting QA Analysts

Monitor QA release data and manage projects to assure expedited turnaround times to meet project deadlines.

Responsible for assisting the QA records management analyst with the daily flow of charts through the file room.

Perform IFG, 1st Review, 2nd Review and Verification of charts, as required.

Monitor and report daily release numbers to QA Management.

Assist on special projects and perform additional duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS

Education:  Bachelor's Degree

Other:  in Science field

 

Years of Experience:  5 - 7 years

Other:   5 + years’ experience in QA related field.

 

Specialized Knowledge, Technical Skills, and Abilities:

Must be self-directed, service and goal oriented, ethical, exhibiting strong communications, supportive to upper management.

Excellent written and verbal communications skills

Excellent computer skills required

 

PREFERRED QUALIFICATIONS

Education:  Master's Degree

Years of Experience:  5 - 7 years

Other:   Engineering experience

Specific Licenses and/or Certifications:   CTBS