Quality & Compliance Specialist

CSL; Westland, Northern (MI, KY); In loco; USD 65.000 - 85.000; Tempo pieno

Descrizione del lavoro

CSL Plasma in Westland, Michigan, is seeking a Quality Specialist to monitor plasma center processes and ensure SOP and regulatory compliance. You will partner with management to keep the center inspection-ready and manage the quality system and training initiatives.

The role requires 3–5 years in quality within plasma or related industries, at least 1 year in a supervisory capacity, and knowledge of cGMP, OSHA, and FDA regulations, along with strong customer service skills.

Competenze

• Bachelor’s/Associate degree in business administration or biological sciences preferred, or equivalent combination of education, training and experience.
• 3-5 years’ experience in quality within Plasma or related industry.
• Minimum 1-year supervisory/leadership experience or equivalent of 1-year experience in a regulated environment.
• Knowledge of cGMP, OHSA, FDA, and other applicable regulations.
• Strong customer service skills.

Mansioni

• Monitor plasma center processes to ensure SOPs and regulatory requirements.
• Partner with management to keep the center inspection-ready at all times by managing the quality system.
• Ensure compliance to quality processes, regulatory requirements, SOPs and training.
• Coordinate training and facilitate timely reporting of deviations to FDA.
• Perform center records quality review for accuracy and timeliness.
• Initiate investigations and develop corrective action plans with management.
• Maintain and update training materials and Learning Management System data integrity.
• Lead internal audits to monitor compliance with SOPs, cGMP, OSHA, FDA and related regs.

Conoscenze

Quality assurance

Regulatory knowledge

Supervisory experience

Customer service

Formazione

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

Descrizione del lavoro

CSL Plasma in Westland, Michigan, is seeking a Quality Specialist to monitor plasma center processes and ensure SOP and regulatory compliance. You will partner with management to keep the center inspection-ready and manage the quality system and training initiatives.

The role requires 3–5 years in quality within plasma or related industries, at least 1 year in a supervisory capacity, and knowledge of cGMP, OSHA, and FDA regulations, along with strong customer service skills.