Quality Assurance Specialist (Quality Control Specialist) - Hiring Immediately

We are hiring an ambitious Quality Assurance Specialist (Quality Control Specialist) to join our awesome team at Indiana University in Indianapolis, IN.
Growing your career as a Full Time Quality Assurance Specialist (Quality Control Specialist) is an amazing opportunity to develop competitive skills.
If you are strong in project management, planning and have the right initiative for the job, then apply for the position of Quality Assurance Specialist (Quality Control Specialist) at Indiana University today!

One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at IU School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. The department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.


Job Summary The Department has been a major support center for clinical gene therapy and the successful candidate will be actively engaged in this exciting and evolving field. Specifically, the Quality Assurance (QA) Specialist will support the department's Gene Therapy Testing Laboratory (GTTL). GTTL is a certification testing laboratory of Indiana University (IU) providing gene therapy resources to academic investigators at IU and external non-profit institutions.


Department-Specific Responsibilities

• Responsible for ensuring a state of control is maintained for the GTTL through reviewing testing records, monitoring training, performing internal audits, and reviewing regulations to ensure compliance is maintained. The IU GTTL is dedicated to testing services for all Phases of clinical research.
• Ensures compliance with the FDA and other regulatory requirements.
• 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 as it pertains to GTTL operations.
• Performs quality audits of the laboratory operations and presents results to leadership. Partners with laboratory leaders and staff to determine appropriate corrective and preventive actions.
• Leads the preparation and management of quality audits conducted by external clients.
• Works in a team environment interacting with laboratory staff, QA staff, and area leadership.

General Responsibilities

• Develops and implements moderately complex project plans consistent 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.
• Collaborates with the research community to disseminate information and develop solutions to address regulatory requirements and contribute to compliance decision making.
• Expands knowledge by managing and participating in various committee meetings and attending workshops and conferences.

Qualifications EDUCATION Required

• Bachelor's degree

Preferred

• Degree in a biologic, health, or compliance-related field from an accredited institution

WORK EXPERIENCE Required

• 3 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, quality assurance, or quality control role supporting a regulated area

Combinations of related education and experience may be considered SKILLS Required

• Demonstrated ability to maintain confidential information
• Demonstrated 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

Working Conditions / Demands 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.


Additional Information This position is grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.


Work Location IUPUI Indianapolis, Indiana


Advertised Salary Selected candidate will be offered $44,241.60 - $64,604.80 per year based on commensurate experience and internal equity within the department.


Benefits Overview 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 .


Job Classification Career Level: Career FLSA: Exempt Job Function: Research Job Family: Research Compliance Click here to learn more about Indiana University's Job Framework.


Posting Disclaimer Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time. 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.


New employees will be provided with information regarding Indiana University's COVID-19 vaccine policy, which includes the opportunity to request an exemption. To learn more, view our COVID-19 vaccine information page . Equal Employment Opportunity 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 .


Campus Safety and Security The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at View email address on click.appcast.io or by visiting IUPD.


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Benefits of working as a Quality Assurance Specialist (Quality Control Specialist) in Indianapolis, IN:

● Excellent benefits
● Opportunities to grow
● Competitive salary