Quality Specialist

CSL; Philadelphia (Philadelphia County); On-site; USD 50,000 - 70,000; Full time

Job summary

CSL is seeking a Quality Specialist to support compliance monitoring and training management at their plasma center. The role involves ensuring adherence to operational procedures and regulatory standards, performing quality assurance reviews, and collaborating on continuous improvement plans. Candidates should have a high school diploma and at least one year of relevant experience, alongside strong organizational and problem-solving skills.

Benefits

Comprehensive health benefits

Life insurance

Disability coverage

401(k)

Paid time off (PTO)

Observed holidays

Qualifications

• Minimum 1 year of leadership or regulated environment experience.
• Understanding of Quality Systems and regulatory training requirements.

Responsibilities

• Monitor compliance with CSL Operating Procedures and regulatory requirements.
• Perform final QA review and release for shipments and related documents.
• Coordinate and manage training activities at the center level.

Skills

Customer Service

Critical Reasoning

Decision-Making

Problem-Solving

Organizational Skills

Attention to Detail

Education

High school diploma or equivalent

Associate or Bachelor’s degree in business administration or biological sciences

Job description

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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 operations and quality requirements for business success.

• Reporting compliance status data to operational quality management
• Collaborating with center management in developing and implementing continuous improvement plans
• Representing the center during internal and external audits in partnership with the Assistant Manager of Quality, responding to questions, and addressing quality concerns, including stopping operations if necessary
• Coordinating and managing training activities, policies, and processes at the center level

The Role

• Performing final QA review and release for shipments and related documents to ensure customer specifications are met
• Ensuring center records QA review for thoroughness, accuracy, and timeliness; initiating investigations and documenting regulatory deficiencies; determining corrective actions and their effectiveness
• Maintaining and reviewing personnel training documents to ensure compliance with CSL procedures, SOPs, CLIA/COLA, and other requirements
• Managing the Learning Management System for data integrity, report generation, and analysis to meet standards
• Scheduling, coordinating, and monitoring training sessions, ensuring current materials are used
• Conducting process assessments to ensure compliance with CSL procedures and developing corrective actions as needed
• Communicating non-conformities and leading internal audits to monitor compliance with CSL policies and regulations, hosting external audits as needed
• Initiating and closing Trackwise reports, ensuring corrective actions are implemented and effective
• Maintaining a clean, safe, and compliant work environment and adhering to HSE and OSHA policies
• Following SOPs, policies, and all applicable laws and regulations
• Maintaining confidentiality of personnel, donor, and center information
• Supporting special projects and 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 of leadership or regulated environment experience
• Strong customer service, critical reasoning, decision-making, and problem-solving skills
• Organizational skills and attention to detail for multitasking and handling shifting priorities
• Understanding of Quality Systems and regulatory training requirements

Working Conditions

• Occasional interaction with dissatisfied public
• 80% standing/walking, 20% sitting
• Ability to reach, bend, kneel, and perform manual tasks
• Ability to lift up to 25 lbs. occasionally
• Exposure to temperature variations, odors, and working with freezers

Our Benefits

CSL offers comprehensive health benefits, life insurance, disability coverage, 401(k), PTO, and observed holidays. More info at cslbenefits.com/cslp.

About CSL Plasma

CSL Plasma is a leading global plasma collection organization, committed to helping people with serious diseases. Learn more about CSL Plasma.

Inclusion & Belonging

We embrace diversity and inclusion. Learn more about our initiatives.

Additional Details

• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Quality Assurance