Plasma Center Quality & Compliance Lead

CSL Plasma; Westland (MI); On-site; USD 85,000 - 110,000; Full time

Job summary

CSL Plasma is seeking a quality professional to monitor plasma center processes and ensure SOP and regulatory compliance. The role partners with management to keep inspections ready at all times by enforcing the quality system and ongoing training.

You will drive investigations, corrective actions, and data integrity across records while leading internal audits to uphold cGMP, OSHA and FDA standards within a fast-paced plasma center environment.

Qualifications

• Bachelor's or Associate in business admin or biological sciences preferred, or equivalent.
• 3–5 years' quality experience in plasma or related industry.
• Minimum 1 year supervisory/leadership experience or equivalent in a regulated environment.
• Knowledge of cGMP, OSHA, FDA, and other applicable regulations.
• Strong customer service skills and problem-solving abilities.

Responsibilities

• Monitors plasma center processes to ensure SOP compliance and regulatory requirements.
• Partners with management to keep the center inspection ready at all times by enforcing SOPs and quality systems.
• Ensures quality processes, regulatory requirements, SOPs and necessary training are followed.
• Coordinates training and timely reporting of deviations to FDA.
• Performs center records quality review for accuracy and timeliness.
• Initiates investigations and develops corrective action plans with management.
• Maintains training materials and LMS data integrity and reporting.
• Leads internal audits to monitor facility compliance with SOPs, cGMP, OHSA, FDA and related regs.

Skills

Customer service

Regulatory awareness

Quality mindset

Leadership

Education

Bachelor's/Associate in Business Admin or Biological Sciences

Job description

CSL Plasma is seeking a quality professional to monitor plasma center processes and ensure SOP and regulatory compliance. The role partners with management to keep inspections ready at all times by enforcing the quality system and ongoing training.

You will drive investigations, corrective actions, and data integrity across records while leading internal audits to uphold cGMP, OSHA and FDA standards within a fast-paced plasma center environment.