Overview
Quality Specialist Jobs in Jackson, Mississippi, USA at Initial Therapeutics, Inc.
The Opportunity
This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance with training needs, SOPs, processes, and other regulatory or company directives to support the operations and quality requirements for business operations.
Reporting compliance status data to operational quality management.
Collaborating with center management in the development and implementation of continuous improvement plans.
Representing the center during internal and external audits alongside the Assistant Manager of Quality, responding to questions, and addressing quality concerns, including halting operations if necessary.
Coordinating and managing training activities, policies, and processes at the center level.
You will report to the Assistant Manager of Quality.
The Role
Performing final QA review and release for all shipments and associated documents to ensure shipments meet customer specifications.
Ensuring center records undergo QA review for thoroughness, accuracy, and timeliness; initiating investigations and documenting regulatory deficiencies; determining the need for corrective actions and assessing their effectiveness.
Maintaining and reviewing plasma center personnel training documents to ensure compliance with CSL procedures, SOPs, CLIA/COLA, and other requirements.
Managing the Learning Management System to ensure data integrity, generate reports, and analyze data to meet standards.
Scheduling, coordinating, and monitoring all training, including new hire, annual, and retraining sessions, ensuring use of the most current training materials.
Collaborating with center management to identify, coordinate, and deliver retraining for operational or quality improvement.
Conducting process assessments to ensure compliance with CSL written procedures and initiating investigations for deficiencies, developing corrective action plans as needed.
Identifying and communicating non-conformities to CSL SOPs; hosting monthly quality team meetings to promote continuous improvement.
Promoting safety, health, and environmental policies; ensuring safety training and practices are followed.
Leading internal audits to monitor compliance with regulations and policies; hosting external audits as needed.
Managing Trackwise reports, ensuring timely investigation and closure of issues, and verifying the effectiveness of corrective actions.
Maintaining a clean, efficient work environment and complying with HSE and OSHA policies.
Following SOPs, company policies, and all applicable regulations.
Maintaining confidentiality of personnel, donor, and center information.
Assisting staff with special projects or assignments and performing other duties as assigned.
Your Skills and Experience
Education
High school diploma or equivalent required; an Associate or Bachelor’s degree in business administration or biological sciences preferred.
Experience
Minimum 1-year leadership or regulated environment experience.
Strong customer service, critical reasoning, decision-making, and problem-solving skills.
Organizational skills and attention to detail for managing multiple tasks and shifting priorities.
Knowledge of Quality Systems and regulated training requirements.
Working Conditions
Occasional interaction with dissatisfied public.
80% standing/walking, 20% sitting.
Ability to reach, bend, kneel, and manual dexterity.
Visual and verbal communication with customers and equipment observation.
Occasional lifting of up to 25 lbs.
Exposure to temperature variations and odors.
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Title: Quality Specialist
Company: Initial Therapeutics, Inc.
Location: Jackson, Mississippi, USA
Category: Quality Assurance – QA/QC, Healthcare
