Quality Assurance Specialist 2, Hoxworth Blood Center, Department of Quality Assurance and Regulatory Compliance
4 weeks ago
SIGN ON BONUS IS AVAILABLE
Hoxworth Blood Center (HBC), a leading blood center in the United States, is seeking a Quality Assurance/Regulatory Compliance (QARC) Specialist 2 to provide support to the QARC Department. The successful candidate will be responsible for ensuring compliance with regulatory requirements and accrediting bodies, with a focus on the Cellular Therapy, Therapeutic Apheresis, and Transplantation Immunology divisions.
The ideal candidate will have a strong background in quality assurance and regulatory compliance, with experience in a regulated environment such as cell therapy, pharmaceutical, or biotech. They will be skilled in tasks required to support QARC, including training QA staff, evaluating compliance of procedures and policies, and performing routine QA and administrative duties.
The QARC Specialist 2 will also be responsible for performing internal and external audits, acting as QA Representative to regulated departments, and reviewing and approving validation documentation. They will work closely with the QARC Department to ensure that all requirements for specific product types are met, and will support the Cellular Therapy Product, raw material, and Master Mix Release program.
The University of Cincinnati offers a competitive salary range, comprehensive insurance plans, flexible spending accounts, and an award-winning employee wellness program. The successful candidate will have the opportunity to work in a dynamic and supportive environment, with a focus on making a positive impact on the lives of others.
Essential Functions
- Provide training to QA staff and education in compliance requirements.
- Skilled in tasks required to support QARC in assigned area of responsibility.
- Evaluate compliance of procedures, policies, and programs. Provides recommendations for improvement.
- Perform routine assigned QA and administrative duties and occasional non-routine program, project support and resolution of issues.
- Perform internal and/or external audits.
- Act as QA Representative to regulated department. Approve procedures and risk assessments. Support Supplier Qualification efforts. Review and approve validation documentation.
- Act as system administrator for Quality Management System (QMS).
- Review and approve calibration and maintenance records.
- Prepare Quality Metric trend reports.
- Administer or perform product recall report review, lookback evaluation, and consignee notifications.
- Initiate deviations, IRIs, and CAPAs. Perform effectiveness checks.
- Support Cellular Therapy (CT) Product, raw material, and Master Mix Release program.
- Ensure all requirement for specific product types are appropriately met. Work with customer representatives on product nonconformances as indicated. Act as delegated authority for final disposition of IND and specific commercial products.
- Attend, contribute to, and lead meetings as requested.
- Follow procedures and policies. Evaluate compliance of own and others work. Supports Hoxworth Blood Center's safety, cGMP, and Quality Plan.
- Perform related duties based on departmental need. This job description may be changed at any time.
- Associate's Degree.
- Four (4) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.
Two (2) years of relevant experience.
Additional Qualifications Considered- A working knowledge of standards or regulations: GMP, GTP, ISO14644, CLIA, AABB, FACT, ASHI.
- Experience reviewing batch production records, label approval and product release, is ideal.
- Expertise performing and supporting compliance audits and self-inspections.
- Experience with Quality Management software and intermediate to advanced skills with Excel, is ideal.
- Quality Assurance experience in a regulated environment (cell therapy, pharmaceutical, or biotech).
- Cleanroom experience is ideal.
- Office environment/no specific unusual physical or environmental demands.
Compensation and Benefits
The University of Cincinnati offers a wide array of complementary and affordable benefit options, to meet the financial, educational, health, and wellness needs of you and your family. Eligibility varies by position and FTE.
- Competitive salary range dependent on the candidate's experience.
- Comprehensive insurance plans including medical, dental, vision, and prescription coverage.
- Flexible spending accounts and an award-winning employee wellness program, plus an employee assistance program.
- Financial security via our life and long-term disability insurance, accident and illness insurance, and retirement savings plans.
- Generous paid time off work options including vacation, sick leave, annual holidays, and winter season days in addition to paid parental leave.
- Tuition remission is available for employees and their eligible dependents.
- Enjoy discounts for on and off-campus activities and services.
As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).
To learn more about why UC is a great place to work, please visit our careers page at https://www.uc.edu/careers.html.
For questions about the UC recruiting process or to request accommodations with the application, please contact Human Resources at jobs@uc.edu.
The University of Cincinnati is an Equal Opportunity Employer.
REQ: 97130
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Cincinnati, Ohio, United States University of Cincinnati Full timeJob OverviewThe University of Cincinnati's Hoxworth Blood Center is seeking a Quality Assurance and Regulatory Compliance Specialist 2 to support the Department of Quality Assurance in ensuring compliance with regulatory requirements and industry standards. This role will provide training to QA staff, evaluate compliance of procedures and policies, and...
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Cincinnati, Ohio, United States University of Cincinnati Full timeKey Responsibilities:The University of Cincinnati's Hoxworth Blood Center is seeking a Quality Assurance Specialist 2 to provide support to the QARC Department. This role will involve ensuring compliance with accrediting bodies and regulations for the Cellular Therapy, Therapeutic Apheresis, and Transplantation Immunology divisions.Key...
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