Description

POSITION SUMMARY:

This position performs a variety of QCU functions to ensure efficient product manufacturing process in support of NMDP's strategic objectives to assure continuing compliance with cellular therapy regulations and promote the highest standards of safety for donors, patients, and products. QCU functions include tracking, verification of accuracy, and final sign off on review of records related to manufacturing process of cellular therapy products. This position also supports the supplier quality program within BioTherapies as well as completes Quality Investigations when capacity allows.

ACCOUNTABILITIES:

Performs Donor Center (DC) and Cord Blood Unit (CBU) Quality Control Review:

• Reviews submitted Donor and Cord Blood Unit eligibility documentation for completeness, accuracy, and compliance with cGMP and NMDP procedures.

• Monitors appropriate deadlines to ensure timely review of Donor and Cord Blood eligibility documentation.

• Collaborates with NMDP staff to problem solve issues that might delay or impede timely completion of Quality Control review.

• Communicates outcome of Quality Control review within required timelines to all involved staff or parties.

• Assists in collection and maintenance of data related to review metrics and error rates.

• Participates in monthly peer review meeting, discusses results, and implements learnings.

Supplier Qualification Program Development and Implementation:

• Work closely with NMDP Supplier Quality team to maintain a robust supplier quality management program.

• Maintain accurate records of supplier quality agreements, questionnaires, and accreditations/certificates.

• Create an approved supplier list that provides detailed and accurate information on suppliers

• Assist in maintaining supplier/vendor relationship management activities.

• Manage/monitor supplier complaints, supplier corrective action reports (SCARs), and change notifications.

Quality Incident and Complaint Management:

• Conducts timely investigations of complex quality incidents and complaints requiring advanced problem solving and operational expertise.

• Coordinates investigations and collaborates with subcontractors, clients, and applicable 3rd parties to ensure appropriate remedial and/or corrective actions are implemented.

Additional Responsibilities:

• Maintains current knowledge of relevant operational processes by attending appropriate internal meetings and completion of appropriate education and training.

• Participates in process improvement efforts applicable to Quality Systems.

• Provides support to NMDP BioTherapies as needed.

• Other duties as assigned.

REQUIRED QUALIFICATIONS:

Knowledge of:

• Basic knowledge of quality and regulatory requirements for pharmaceutical, biologic, or medical device preferred, including Good Manufacturing Practices (GMP), Good Tissue Practices (GTP), and Good Documentation Practices (GDP).

• Quality management principles and understanding of biological product manufacturing process preferred.

• Quality system elements including risk management, CAPA, change control, and management review.

• HIPPA and donor/patient confidentiality

• FDA regulations applicable to cell therapy (preferably 21 CFR 1271, Good Tissue Practices, 21 CFR 211, Good Manufacturing Practices - Drugs and Pharmaceuticals, and 21 CFR Part 11, Electronic Records).

Ability to:

• Demonstrate excellent oral and written communication skills and advanced interpersonal skills.

• Show strong attention to detail and demonstrate excellent organizational skills.

• Accurately and efficiently review and complete data forms.

• Work flexible hours outside of core business hours (evenings, weekends, and some holidays) approximately one week per month.

• Demonstrate complex problem solving, critical thinking, and decision-making abilities.

• Utilize critical thinking skills and deal with ambiguity.

• Seek guidance to make decisions based on best information available and determine appropriate course of action.

• Appropriately manage escalation of issues when necessary.

• Prioritize multiple tasks and deliverables while maintaining attention to detail.

• Work independently and as part of a team.

• Provide exceptional customer service.

• Demonstrate strong interpersonal skills

• Proficiently use relevant NMDP computer software applications

• Proven proficiency with Windows, Word, Excel, PowerPoint, internet, and databases preferred

• Exemplify our NMDP standards.

Education and/or Experience:

• Bachelor's degree in health or biological sciences, medical terminology or other science-related field preferred. However, upon evaluation, equivalent experience, or related education in addition to the required experience may be substituted for the specific degree requirements.

• Two years of experience working in a regulated or manufacturing environment.

• Knowledge of FDA's Good Tissue Practices (GTP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) preferred.

• Experience with medical and/or confidential documents.Responsibilities

POSITION SUMMARY:

This position performs a variety of QCU functions to ensure efficient product manufacturing process in support of NMDP's strategic objectives to assure continuing compliance with cellular therapy regulations and promote the highest standards of safety for donors, patients, and products. QCU functions include tracking, verification of accuracy, and final sign off on review of records related to manufacturing process of cellular therapy products. This position also supports the supplier quality program within BioTherapies as well as completes Quality Investigations when capacity allows.

ACCOUNTABILITIES:

Performs Donor Center (DC) and Cord Blood Unit (CBU) Quality Control Review:

• Reviews submitted Donor and Cord Blood Unit eligibility documentation for completeness, accuracy, and compliance with cGMP and NMDP procedures.

• Monitors appropriate deadlines to ensure timely review of Donor and Cord Blood eligibility documentation.

• Collaborates with NMDP staff to problem solve issues that might delay or impede timely completion of Quality Control review.

• Communicates outcome of Quality Control review within required timelines to all involved staff or parties.

• Assists in collection and maintenance of data related to review metrics and error rates.

• Participates in monthly peer review meeting, discusses results, and implements learnings.

Supplier Qualification Program Development and Implementation:

• Work closely with NMDP Supplier Quality team to maintain a robust supplier quality management program.

• Maintain accurate records of supplier quality agreements, questionnaires, and accreditations/certificates.

• Create an approved supplier list that provides detailed and accurate information on suppliers

• Assist in maintaining supplier/vendor relationship management activities.

• Manage/monitor supplier complaints, supplier corrective action reports (SCARs), and change notifications.

Quality Incident and Complaint Management:

• Conducts timely investigations of complex quality incidents and complaints requiring advanced problem solving and operational expertise.

• Coordinates investigations and collaborates with subcontractors, clients, and applicable 3rd parties to ensure appropriate remedial and/or corrective actions are implemented.

Additional Responsibilities:

• Maintains current knowledge of relevant operational processes by attending appropriate internal meetings and completion of appropriate education and training.

• Participates in process improvement efforts applicable to Quality Systems.

• Provides support to NMDP BioTherapies as needed.

• Other duties as assigned.

REQUIRED QUALIFICATIONS:

Knowledge of:

• Basic knowledge of quality and regulatory requirements for pharmaceutical, biologic, or medical device preferred, including Good Manufacturing Practices (GMP), Good Tissue Practices (GTP), and Good Documentation Practices (GDP).

• Quality management principles and understanding of biological product manufacturing process preferred.

• Quality system elements including risk management, CAPA, change control, and management review.

• HIPPA and donor/patient confidentiality

• FDA regulations applicable to cell therapy (preferably 21 CFR 1271, Good Tissue Practices, 21 CFR 211, Good Manufacturing Practices - Drugs and Pharmaceuticals, and 21 CFR Part 11, Electronic Records).

Ability to:

• Demonstrate excellent oral and written communication skills and advanced interpersonal skills.

• Show strong attention to detail and demonstrate excellent organizational skills.

• Accurately and efficiently review and complete data forms.

• Work flexible hours outside of core business hours (evenings, weekends, and some holidays) approximately one week per month.

• Demonstrate complex problem solving, critical thinking, and decision-making abilities.

• Utilize critical thinking skills and deal with ambiguity.

• Seek guidance to make decisions based on best information available and determine appropriate course of action.

• Appropriately manage escalation of issues when necessary.

• Prioritize multiple tasks and deliverables while maintaining attention to detail.

• Work independently and as part of a team.

• Provide exceptional customer service.

• Demonstrate strong interpersonal skills

• Proficiently use relevant NMDP computer software applications

• Proven proficiency with Windows, Word, Excel, PowerPoint, internet, and databases preferred

• Exemplify our NMDP standards.

Education and/or Experience:

• Bachelor's degree in health or biological sciences, medical terminology or other science-related field preferred. However, upon evaluation, equivalent experience, or related education in addition to the required experience may be substituted for the specific degree requirements.

• Two years of experience working in a regulated or manufacturing environment.

• Knowledge of FDA's Good Tissue Practices (GTP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) preferred.

• Experience with medical and/or confidential documents.