Career Center

SCHOOL WIDE RESEARCH (IN-RESW-IUINA)

Department Information

The Indiana University School of Medicine (IUSM) supports innovative and collaborative basic, clinical, and translational research on a broad range of key scientific, medical, and health care topics. The IUSM is dedicated to the highest quality research and is committed to a culture of quality by providing Quality Assurance (QA) support and a strong Quality Management System across its areas. The Quality Assurance Specialist position offers diversity in responsibilities and in areas of quality expertise (e.g., FDA GMPs, GCPs, and GLPs), because this position supports multiple IUSM departments including:

* Clinical and Translational Support Laboratory (CTSL). The CTSL provides SOP-driven, protocol-specific processing and shipping services for studies collecting human derived research specimens. The highest levels of quality and consistency are assured through compliance to GCPs and GLPs.

* Indiana CTSI Specimen Storage Facility (SSF). The SSF is committed to providing a storage facility for Principal Investigators performing bio-banking activities in compliance with ISBER (International Society for Biological and Environmental Repositories) guidelines and best practices.

* Vector Production Facility (VPF). The VPF manufactures GMP retroviral and lentiviral products as well as master cell banks intended for use in pre-clinical and Phase I and I/II gene therapy clinical trials.

* Gene Therapy Testing Laboratory (GTTL). The GTTL is a certification testing laboratory providing gene therapy resources to academic investigators at IU and external non-profit institutions. The GTTL is dedicated to testing services for all Phases of clinical research and is governed by GMP requirements.

Department Specific Responsibilities

• Supports and provides quality leadership to the CTSL and SSF.
• Ensures compliance with applicable regulatory requirements and guidelines.
• Maintains the quality management system including procedures, staff training, and quality metrics.
• Independently manages regular quality activities including review and approval of documentation (e.g., equipment qualification, logs, reports), inspection of area practices, management of deviations, and control of area access.
• Performs quality audits and presenting results to leadership. Partnering with leaders and staff to determine appropriate corrective and preventive actions.
• Improves organizational performance through recommending areas or approaches for improvement activities, collecting data, and providing input to departmental discussions.
• Initiates quality improvements to ensure Standard Operating Procedures (SOPs) and regulatory compliance.
• Attends and actively participates in regular management meetings.
• Supports and provides QA leadership to IUSM-wide initiatives such as the Freezer Management Project. This project assures freezer management compliance across the IUSM laboratory freezers that store critical samples.
• Provides document management oversight of VPF and GTTL GMP records including record archiving, auditing, and making recommendations for ongoing improvement.

General Responsibilities

• Develops and implements complex project plans and ensures consistency with the requirements of current and new federal, state, and local regulations and statutes as well as the compliance policies of the University.
• Manages implemented project plans including maintenance of program documentation, performance of training, monitoring and auditing.
• Collaborates with key research and operational stakeholders at IU to identify research compliance gaps, find solutions to mitigate risks and implement project plans.
• Continuously monitors regulatory changes and determine impact on research community.
• Serves on committees to provide advice and make recommendations to members and committee chairs, university counsel, senior administrators, faculty investigators, and other affiliated institutions as it relates to research.
• Develops and conducts training programs and conferences regarding research for committee members, faculty investigators, administrators, and staff.
• May serve as lead for major projects/initiatives; provides guidance and support to junior-level peers.

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

EDUCATION

Required

• Bachelor's degree (preferably in biologic, health, or compliance-related field from an accredited institution)

Preferred

• Master's degree in a related discipline

WORK EXPERIENCE

Required

• 5 years of relevant work experience in a sponsored research, compliance, healthcare, or clinical setting

Preferred

• 3 years of relevant work or educational experience in a laboratory, biorepository, manufacturing, quality assurance, or quality control role supporting a regulated area

SKILLS

Required

• Demonstrates ability to maintain confidential information
• Demonstrates analytical skills
• Excellent organizational skills
• Proficient communication skills
• Demonstrates excellent judgment and decision making skills
• Experience in a regulated environment
• Excellent collaboration and team building skills
• Maintains composure under pressure
• Ability to work within tight time frames and meet strict deadlines
• Demonstrates problem solving skills
• Strong verbal communication and listening skills
• Ability to lead/manage others

This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment and the campus. The person in this role must be able to perform the essential functions with or without an accommodation.

Indianapolis, Indiana

For full-time staff employees, Indiana University offers a wide array of benefits including:

• Multiple plan options for medical insurance
• Dental insurance
• Health Savings Account with generous IU contribution
• Life insurance, LTD, and AD&D options
• Base retirement plan contribution from IU, subject to vesting
• Additional supplemental retirement plan options
• Tuition benefit for IU classes
• 10 paid holidays per year
• Generous Paid Time Off
• Paid Parental Leave
• Employee Assistance Program (EAP)

Learn more about our benefits by reviewing our online Benefits Brochure.

Career Level: Advanced

FLSA: Exempt

Job Function: Research

Job Family: Research Compliance

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This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.

If you wish to include a cover letter, you may include it with your resume when uploading attachments.

Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information.

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