Quality Assurance Associate - Midwest Stem Cell

The University of Kansas Health System; Kansas City (MO); Presencial; USD 34 000 - 50 000; Tempo parcial

Resumo da oferta

The University of Kansas Health System's Midwest Stem Cell Therapy Center is seeking a Quality Assurance Associate to perform QA and regulatory work for the GMP facility, ensuring FDA compliance and maintaining SOPs, forms and quality systems. You will assist with documentation, audits, and regulatory activities in a part-time role at the Kansas City campus.

Under the Associate Director, you will support batch record review, deviations, CAPAs, training, and cross-functional collaboration to

Qualificações

• Four (4) years of experience in a regulated laboratory or manufacturing environment.
• Bachelor’s degree in biology, life science or a related field.
• Experience with FDA regulations and GMP/GTP environments.

Responsabilidades

• Performs QA and regulatory responsibilities for GMP/GTP facility operations.
• Maintain compliance with FDA regulations and other authorities.
• Develop, review, update SOPs and quality system documents.
• Manage document control, batch records review, and training records.
• Support internal audits, deviations, CAPAs, and quality events.
• Ensure proper equipment and GMP environment maintenance.
• Coordinate with other university areas to support institutional mission.

Descrição da oferta de emprego

Department:

Stem Cell Therapy Center

Stem Cell Therapy Center

Position Title:

Quality Assurance Associate - Midwest Stem Cell

Job Family Group:

Professional Staff

Job Description Summary:

The Quality Assurance Associate performs all aspects of quality assurance and regulatory work as related to the operation of the GMP facility within the Midwest Stem Cell Therapy Center at KUMC. The role follows established standards and regulatory practices to keep the facility in full compliance with the FDA and other regulatory authorities. Assists with the development, review, revision, and maintenance of Standard Operating Procedures (SOPs), forms, and other quality system documents as needed.

Job Description:

Key Roles and Responsibilities:

• Performs all quality assurance and regulatory responsibilities associated with the operation of the Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) facility within the Midwest Stem Cell Therapy Center at KUMC.
• Perform all work in compliance with all established standards and regulatory practices to keep the facility in full compliance with the FDA and other regulatory authorities.
• Under the direction of Associate Director, Midwest Stem Cell Therapy Center, document, develop, update, and modify the various Standard Operating Procedures and other quality system documents as often as necessary based on change in protocols.
• Maintain a thorough knowledge and be well versed in all applicable FDA regulations, especially those pertaining to manufacturing and controls, (cGMPs 21 CFR 210 and 211) and tissue regulation (cGTPs 21 CFR 1271).
• Responsible for QA aspects of clinical supply manufacturing, testing, packaging, storing and shipping operations.
• Assists with document management and batch record review.
• Perform and maintain internal audit/review systems.
• Responsible for equipment and GMP environment maintenance.
• Assists with documenting and investigating deviations, nonconformances, CAPAs, and other quality events.
• Will maintain relevant logbooks and ongoing documentation as required by the procedures and practices within the GMP facility
• Assist in training of all employees and management of training records and reports.
• Conducts activities in a professional and ethical manner, and in accordance with KUMC Policies and applicable local, state and federal laws and regulations.
• Performs job responsibilities in a safe and secure manner.
• Coordinate work with other University areas ensure integration and support of the University mission.
• Develops, maintains and expands job-specific knowledge and skills to keep pace with industry changes and supports the university’s commitment to excellence and innovation.
• Participates in relevant committees, task force, or other similar activities.
• Maintain confidentiality of medical center, employee, and patient information. Manages sensitive data with discretion and in accordance with KUMC policies and legal requirements.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.

Required Qualifications

Work Experience:

• Four (4) years of experience working in a regulated laboratory or manufacturing environment, such as GMP, GTP, CLIA, CAP, FDA-regulated, or equivalent settings. Education may substitute for experience on a year for year basis.

Preferred Qualifications

Education

• Bachelor’s degree in biology, life science or a related field.

Work Experience:

• Experience in a GMP environment for the manufacture of cellular therapy products
• Experience and working knowledge of FDA regulations, especially those pertaining to current Good Manufacturing Practices (cGMP; 21 CFR Parts 210 and 211) and current Good Tissue Practices (cGTP; 21 CFR Part 1271).

Skills

• Detail oriented
• Analytical thinking
• Organization

Required Documents

Resume

Cover Letter

Comprehensive Benefits Package:

Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. https://www.kumc.edu/human-resources/benefits.html

Employee Type:

Regular

Time Type:

Part time

Rate Type:

Hourly

Compensation Statement:

The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.

Pay Range:

$24.71 - $35.82

Minimum

$24.71

Midpoint

$30.29

Maximum

$35.82