Quality Assurance Team Lead - St. Mary's

Select Medical•Addison, TX

23h

About The Position

Concentra is recognized as the nation’s leading occupational health care company. With more than 40 years of experience, Concentra is dedicated to our mission to improve the health of America’s workforce, one patient at a time. With a wide range of services and proactive approaches to care, Concentra colleagues provide exceptional service to employers and exceptional care to their employees. The Team Lead, Quality Control at St. Mary’s Medical Park Pharmacy (Concentra) performs daily quality control tasks for the repackaging/relabeling department in accordance with St. Mary’s policies and procedures to ensure FDA 211 cGMP compliance and all other duties assigned by the Director of Quality.

Requirements

Education Level: High School Diploma or GED
3-5 years at a workplace that was responsible for maintaining FDA 211 cGMP compliance
Concentra Core Competencies of Service Mentality, Attention to Detail, Sense of Urgency, Initiative and Flexibility
Ability to make decisions or solve problems by using logic to identify key facts, explore alternatives, and propose quality solutions
Outstanding customer service skills as well as the ability to deal with people in a manner which shows tact and professionalism
The ability to properly handle sensitive and confidential information (including HIPAA and PHI) in accordance with federal and state laws and company policies
Must be very detail oriented.
Excellent time management and organizational skills
Exceptional ability to collaborate with fellow colleagues.
Must be able to multi-task and prioritize effectively.
Ability to make decisions or solve problems by using logic to identify key facts, explore alternatives, and propose quality solutions.
Ability to work independently within guidelines and company policies.
Familiarity with Microsoft Excel, Outlook, Word experience required

Responsibilities

Responsible for day-to-day approval or rejection of all primary package components, in-process materials, packaging materials, labeling, and drug products at St. Mary’s Medical Park Pharmacy.
Receiving Department: Quality Control Lead is responsible for approving or rejecting and documenting, all medications, packaging components and returns.
Labeling Department: Quality Control Lead is responsible for approving or rejecting and documentation of products that are labeled or relabeled.
Repackaging Department: the Quality Lead Supervisor is responsible approving or rejecting and documenting the cleanliness of repackaged rooms prior to initiation of the repackaging of a product. The role and team are responsible for approving or rejecting and documenting all batches of repackaged, relabeled and passthrough products at St. Mary’s.
Assists the Director of Quality in staff training exercises related to Quality Assurance and Quality Control
Works with the Director of Quality in investigations related to Quality Assurance and Quality Control including investigations on deviations, complaints, recalls, and Corrective Actions and Preventive Actions (CAPA).
Collaborates with the Director of Quality in organizing and execution of quarterly Quality Unit meetings.