Quality Specialist

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

Job summary

CSL Plasma is seeking a Quality Assurance Coordinator to support compliance and training efforts at their plasma center. The role involves monitoring processes, conducting audits, and collaborating with management for continuous improvement. Ideal candidates will have a high school diploma and experience in a regulated environment, along with strong organizational and problem-solving skills. Join CSL Plasma to make a difference in the lives of those with serious diseases.

Benefits

Health benefits

Life insurance

Disability coverage

401(k)

PTO

Holidays

Qualifications

• Minimum 1-year leadership or regulated environment experience.
• Strong customer service and problem-solving skills.
• Knowledge of Quality Systems and regulated training requirements.

Responsibilities

• Monitor compliance with CSL Operating Procedures and regulatory requirements.
• Manage training activities and ensure adherence to SOPs.
• Lead internal audits and address quality concerns.

Skills

Customer Service

Critical Reasoning

Decision-Making

Problem-Solving

Organizational Skills

Attention to Detail

Knowledge of Quality Systems

Education

High school diploma or equivalent

Associate or Bachelor’s in business administration or biological sciences

Job description

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, and federal requirements. The role will ensure adherence to training needs, SOPs, processes, and other regulatory or company directives to support operations and quality requirements.

1. Report compliance status data to operational quality management.
2. Collaborate with center management to develop and implement continuous improvement plans.
3. Represent the center during internal and external audits, respond to questions, and address quality concerns, including halting operations if necessary.
4. Coordinate and manage training activities, policies, and processes at the center level.

You will report to the Assistant Manager of Quality.

The Role

1. Perform final QA review and release for shipments and associated documents, ensuring they meet customer specifications.
2. Ensure center records undergo QA review for thoroughness, accuracy, and timeliness; investigate deficiencies and implement corrective actions.
3. Maintain and review personnel training documents to ensure compliance with CSL procedures, SOPs, CLIA/COLA, and other requirements.
4. Manage the Learning Management System for data integrity, reporting, and analysis to meet standards.
5. Schedule, coordinate, and monitor training sessions, ensuring the use of current materials.
6. Collaborate with management to identify, coordinate, and deliver retraining to improve operational or quality issues.
7. Conduct process assessments for compliance, document deficiencies, and develop corrective actions.
8. Identify and communicate non-conformities to SOPs; lead or participate in quality meetings to promote continuous improvement.
9. Promote safety, health, and environmental policies; ensure safety practices are followed.
10. Lead internal audits for compliance with regulations and policies; host external audits when necessary.
11. Manage Trackwise reports, ensuring timely investigation and closure of issues.
12. Maintain a clean work environment and ensure compliance with HSE and OSHA policies.
13. Follow SOPs, policies, and regulations such as ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, OSHA.
14. Maintain confidentiality of personnel, donor, and center information.
15. Assist staff with special projects and other duties as assigned.

Your Skills and Experience

Education

High school diploma or equivalent required; Associate or Bachelor’s 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.
• Knowledge of Quality Systems and regulated training requirements.

Working Conditions

• Occasional interaction with dissatisfied public.
• 80% standing/walking, 20% sitting.
• Reaching, bending, kneeling, manual dexterity.
• Ability to lift up to 25 lbs.
• Exposure to temperature variations, odors, working with freezers.

Our Benefits

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

About CSL Plasma

We are one of the world's largest plasma collectors, committed to helping those with serious diseases. Learn more at CSL Plasma.

We value diversity and inclusion

Join us in reflecting the world around us. Learn more at Inclusion & Belonging.

Make a difference at CSL Plasma!