Overview
Quality Assurance Specialist – Cord Blood Bank Program (Variable shift) Jobs in Houston, TX at MD Anderson Cancer Center
Benefits:
Health care insurance (medical, dental, vision)
Company Paid Life Insurance
Supplemental Insurance
PTO
401K matching
Sick leave
Phone/internet reimbursement
Remote work
Bereavement Leave
Paid Holidays
Paid Jury Duty
Role Summary
The primary function of the Quality Assurance Manager is to maintain quality systems, drive continuous process improvement, and ensure compounding is performed according to regulatory standards and industry best practices for all assigned 503 A compounding pharmacies in the Revelation network.
Responsibilities
Works with senior leadership to develop, implement, and maintain successful RPC quality and regulatory strategies for corporate quality systems and respective pharmacies, including:
Articulating quality standards and objectives to pharmacies and RPC departments
Developing methods to embed quality into compounding processes for 503A facilities
Establishing vendor relationships and standards
Overseeing processes for internal and external quality audits
Maintaining inspection readiness and responding to findings from audits
Develop, implement, and maintain SOPs, training and competency assessment material, and gap analysis tools
Proactively partner with R&D, Marketing, Clinical and other RPC teams to provide regulatory advice and guidance on meeting necessary requirements
Oversee employee development, processes, and technology necessary to reach annual and long-term objectives established by executive leadership and the Board of Directors
Works alongside RPC departments to support corporate goal of instilling a Culture of Excellence, Financial Performance, and Focus on Quality with all RPC employees
Qualifications and Education Requirements
Bachelor’s degree preferred
Minimum of 5 years of experience in quality leadership roles
3 years of experience in compounding pharmacy or related field
Extensive experience hosting regulatory inspections and interacting with regulatory bodies.
Broad knowledge base of cGMP, FDA, USP, GFIs, CPGs and applicable regulations and industry standards regarding regulation of 503a compounding pharmacies.
Effective leader with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management
Public speaking and teaching ability, both in-person and through virtual platforms
Proven ability to create culture of accountability and ownership
Physical Requirements:
Proficient in using a computer and related equipment, including printers and fax machines.
Ability to sit or stand for extended periods.
Effective communication skills via telephone and email.
Capable of lifting up to 40 pounds as needed.
20/20 vision (with or without corrective aids)
Required Tools
Laptop and computer workstation
Cell Phone
Access to RPC software subscriptions
Key Performance Metrics
EBITDA
Revenue Projections
Successful onboarding and integration of new RPC pharmacies
Staff Attrition
Employee Satisfaction
Quality Assurance Program
Successful inspections from internal and external audits, with timely response to all deficiencies
Compliance with USP, state and federal regulatory requirements
Maintenance of compliance with RPC SOPs
Best practice application of industry standards
Minimal production disruption due to regulatory or process non-compliance
Title: Quality Assurance Specialist – Cord Blood Bank Program (Variable shift)
Company: MD Anderson Cancer Center
Location: Houston, TX
