Quality Assurance Assistant Manager

1 week ago

Toledo, Ohio, United States CSL Plasma Full time

Position Overview
As a Quality Assurance Assistant Manager, you will play a pivotal role in ensuring that our center maintains the highest standards of quality and compliance. Your leadership will be essential in fostering a culture of excellence and adherence to established protocols.

Key Responsibilities

  • Maintain a state of readiness for inspections by overseeing compliance with Standard Operating Procedures (SOPs) and quality systems. Regularly prepare and present reports on quality status to management.
  • Oversee the Quality Control program, including calibrations, compliance monitoring, and performance metrics analysis. Implement corrective actions based on root cause assessments.
  • Develop and mentor your team, ensuring they possess the necessary skills for their roles. Lead recruitment, performance evaluations, and necessary corrective actions.
  • Collaborate with management to enhance operational processes, improving service delivery and financial outcomes while ensuring compliance.
  • Provide constructive feedback to staff regarding adherence to Good Manufacturing Practices (GMP) and address any compliance issues promptly.
  • Act as the primary quality representative during audits, coordinating remediation efforts and ensuring timely resolution of findings.
  • Ensure a safe and efficient work environment, adhering to all Health, Safety, and Environmental (HSE) regulations.
  • Uphold all HR policies, ensuring fair treatment of all employees and effective communication with HR for compliance.
  • Report any incidents that may compromise product safety or quality to the appropriate management levels.
  • Maintain confidentiality regarding all sensitive information related to personnel and operations.
  • Lead investigations into deviations, ensuring thorough root cause analysis and effective corrective actions.
  • Perform additional duties as assigned.

Qualifications

  • Bachelor's Degree in a relevant field is preferred.
  • At least 1 year of supervisory experience or quality-related experience is required.
  • Completion of a leadership development program is advantageous.
  • Knowledge of regulatory requirements and compliance monitoring is essential.
  • Strong decision-making skills and the ability to produce comprehensive reports.
  • Ability to work in a fast-paced environment with exposure to various physical demands.

Working Conditions
This role may require occasional travel and involves working in environments with potential exposure to hazardous materials. Personal Protective Equipment (PPE) must be worn as required.

About CSL Plasma
CSL Plasma is a leading organization in the collection of human plasma, dedicated to improving the lives of individuals with rare and serious diseases. We are committed to diversity and inclusion within our workforce.

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