Job Description:
Current Employees:
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The University of Miami/UHealth Department of ISCI Laboratory Operations has an exciting opportunity for a Quality Coordinator. The Quality Coordinator ensures that the Contact Center Team maintains service level expectations and adheres to established policies and guidelines. This position supervises junior staff members and participates in training initiatives to ensure optimum efficiency within the unit.
Core Job Functions
Serves as the quality assurance team lead, role model, and subject matter expert for staff. Provides performance coaching and support to phone colleagues, including development of tracking tools and aids. Coordinates the daily work activities of the Quality Assurance Team. Completes weekly scorecards for all team members. Monitors, listens, and evaluates inbound customer calls and emails. Holds one-on-one meetings with staff to provide coaching and feedback. Works with management to set Call Quality Standards based on industry best practices. Participates in the development and improvement of call monitoring formats and quality standards. Assists management in the recruitment, selection, and onboarding of quality analysts. Prepares and analyzes internal and external quality reports for management staff review. Coordinates and co-leads quarterly calibration meetings with supervisors and team leads to ensure consistency in scoring methodologies. Maintains data collection for quality assurance metrics within internal departmental database. Tracks internal quality scores, identifies quality trends, and suggests action items to senior staff. Adheres to University and unit-level policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
Core Qualifications
Education:
Bachelor's Degree in relevant field
Experience:
Minimum 2 year of experience
Any appropriate combination of relevant education, experience and/or certifications may be considered.
Knowledge, Skills and Attitudes:
- Ability to communicate effectively in both oral and written form.
- Ability to maintain effective interpersonal relationships.
- Ability to work independently and/or in a collaborative environment.
- Skill in collecting, organizing and analyzing data.
- Skill in completing assignments accurately and with attention to detail.
- Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
Department Specific Functions:
- Assist in QC systems for biologics production, ensuring compliance with GMP regulations and industry standards.
- Documentation: Maintains detailed QC records, including test results, deviations, and CAPA actions, ensuring compliance with regulatory (FDA, GMP) and internal standards.
- Product Testing and Validation: Perform regular product testing of raw materials, in-process products, and finished products to ensure they meet quality specifications.
- Validate analytical methods and ensure consistent test results. supporting R&D through testing and process improvements Assist and support quality systems, investigating process deviations, in support of the Quality Assurance Manager.
- Assist in drafting, formatting, and compiling IND sections, including nonclinical, clinical, and CMC (Chemistry, Manufacturing, and Controls) documentation. Assist with reviewing batch records, analytical test results, and Certificates of Analysis (COAs).
- Support follow-up and closure of deviations, incidents, and positive microbial cases, ensuring corrective and preventive actions are completed Maintain an updated index of all SOPs, file obsolete SOPs, and ensure adequate documentation of SOP changes.
- Assist in ensuring Standard Operating Procedures (SOPs) accurately describe procedures, are developed for all administrative, processing, and equipment operations, and are reviewed at least annually.
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
H7
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