Overview
Quality Specialist Jobs in Wichita, Kansas, USA at BioSpace
Join to apply for the
Quality Specialist
role at
Bio Space
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. The role will ensure adherence to training needs, SOPs, processes, and other regulatory or company directives to support business operations and quality requirements.
Key Responsibilities
Report compliance status data to operational quality management.
Collaborate with center management to develop and implement continuous improvement plans.
Represent the center during internal and external audits, 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 shipments and associated documents to ensure they meet customer specifications.
Ensure thorough, accurate, and timely review of center records; initiate investigations and document deficiencies; determine 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 training, including new hire, annual, and retraining sessions.
Conduct process assessments to ensure compliance with CSL procedures and initiate corrective actions as needed.
Identify and communicate non-conformities, lead quality team meetings, and promote continuous improvement.
Promote safety policies, conduct internal audits, and host external audits when necessary.
Manage Trackwise reports, ensuring timely investigations and corrective actions.
Maintain a clean and safe work environment and comply with HSE and OSHA policies.
Follow SOPs, company policies, and legal regulations, maintaining confidentiality.
Assist with special projects and other duties as assigned.
Your Skills
and Experience
Education
High school diploma or equivalent required;
Associate or Bachelor’s degree preferred.
Experience
Minimum 1-year leadership or regulated environment experience.
Strong customer service, decision-making, problem-solving, and organizational skills.
Knowledge of Quality Systems and regulatory training requirements.
Working Conditions
Occasional interaction with dissatisfied public.
80% standing/walking, 20% sitting.
Manual dexterity, ability to lift 25 lbs., exposure to temperature variations and odors.
Benefits
Health, dental, vision, life insurance, disability, 401(k), PTO, holidays, and more. More details at
About CSL Plasma
One of the world’s largest plasma collectors, committed to helping people with serious diseases. Learn more at CSL Plasma.
Our
Commitment to Diversity
CSL values diversity and inclusion. Learn more about our initiatives.
Job Details
Seniority level:
Entry level
Employment type:
Full-time
Job function:
Quality Assurance
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Title: Quality Specialist
Company: BioSpace
Location: Wichita, Kansas, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, QA Specialist / Manager, Quality Technician/ Inspector)
