Overview
Quality Specialist Jobs in Spartanburg, South Carolina, USA at BioSpace
Join or sign in to find your next job
Join to apply for the Quality Specialist role at Bio Space
2 days ago Be among the first 25 applicants
Join to apply for the Quality Specialist role at Bio Space
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 to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.
Reporting compliance status data to operational quality management
Collaborate with center management in the development and implementation of continuous improvement plans
Represent the center during internal and external audits in collaboration with the Assistant Manager of Quality, respond to questions, and address quality concerns, including stopping operations if necessary
Coordinate and manage training activities, policies, and processes at the center level
You will report to the Assistant Manager of Quality.
The Role
Perform final QA review and release for all shipments and associated documents to ensure they meet customer specifications
Ensure thorough, accurate, and timely review of center records; initiate investigations for regulatory deficiencies; determine and document corrective actions and their effectiveness
Maintain and review personnel training documents to ensure compliance with CSL procedures, SOPs, CLIA/COLA, and other requirements
Manage the Learning Management System for data integrity, reporting, and analysis
Coordinate and monitor delivery of all training, including new hire, annual, and retraining, ensuring current training materials are used
Identify, coordinate, and deliver retraining to address operational or quality issues
Conduct process assessments to ensure compliance with CSL procedures and develop corrective action plans as needed
Identify and communicate non-conformities, lead internal audits, and host external audits by regulatory agencies and customers
Manage Trackwise reports, investigate issues, and ensure effective corrective actions
Maintain a clean, safe work environment and ensure compliance with HSE and OSHA policies
Follow SOPs, company policies, and all applicable regulations
Maintain confidentiality of all personnel, donor, and center information
Assist staff with other projects or assignments as needed
Your Skills and Experience
Education
High school diploma or equivalent required;
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
Understanding of Quality Systems and regulated training requirements
Working Conditions
Occasional interaction with dissatisfied public
80% standing/walking, 20% sitting
Reach, bend, kneel, manual dexterity
Ability to lift and carry 25 lbs occasionally
Exposure to temperature variations, odors, and working with freezers
Our Benefits
CSL offers health benefits, life insurance, disability, 401(k), PTO, holidays, and more. For details, visit
About CSL Plasma
CSL Plasma is a leading plasma collection organization dedicated to helping people with serious diseases. Learn more about CSL Plasma.
Our Commitment to Diversity
We embrace diversity and inclusion across our global organization. Learn more about our initiatives.
Job Details
Seniority level:
Entry level
Employment type:
Full-time
Job function:
Quality Assurance
#J-18808-Lj…
Title: Quality Specialist
Company: BioSpace
Location: Spartanburg, South Carolina, USA
Category: Quality Assurance – QA/QC (QA Specialist / Manager, Quality Control / Manager, Quality Technician/ Inspector)
