What are the responsibilities and job description for the Center Quality Manager position at Kamada?
Who We Are: Kamada Plasma, a subsidiary of Kamada Ltd., operates a specialized plasma collection center in Beaumont, TX. As a leading U.S. provider, we are FDA licensed and certified by PPTA and CLIA, utilizing advanced automated technology. We focus on collecting plasma for life-saving medications, including specialty programs for rare diseases and critical immunoglobulins. Our Beaumont Center, established in 1967, is renowned for its dedication to innovation and excellence in plasma-related services. We are committed to impacting global healthcare and saving lives through the collection of rare donor human plasma.
About the Role: We are seeking a dedicated and detail-oriented Center Quality Manager to oversee daily quality operations at our Beaumont plasma collection center. This role is pivotal in maintaining regulatory adherence and fostering a culture of continuous improvement. Reporting directly to the US Plasma Quality Director and collaborating closely with Center Managers, you will ensure the highest standards of quality, safety, and compliance.
Responsibilities:
- Manage daily quality operations, ensuring compliance with regulatory and internal standards.
- Conduct thorough reviews of quality-related records and oversee production processes to identify and correct discrepancies.
- Implement corrective actions to uphold the highest standards of quality and safety.
- Drive process improvements through regular GEMBA walks and direct observation.
- Lead deviation and CAPA management, ensuring timely resolution and implementation of preventive measures.
- Facilitate Quality Council meetings to drive key quality initiatives.
- Conduct internal audits to ensure adherence to SOPs and regulatory standards.
Why Work at Kamada Plasma? Join our dedicated team committed to excellence in plasma collection and improving lives daily through innovative plasma-derived therapies. We offer a rewarding and intellectually stimulating career in a supportive environment that fosters professional growth and offers diverse opportunities to expand your expertise within the field. Enjoy a competitive compensation package, including a base salary commensurate with experience, medical, dental, and vision coverage, 401k matching, holidays, and PTO. This full-time salaried exempt position requires a minimum of 40 hours per week at the center.
What You'll Bring:
- Experience: 3-5 years in a regulated environment (plasma collection preferred), demonstrating a strong understanding of quality management principles.
- Knowledge: Proficiency in FDA, GMP, PPTA, and CLIA standards, ensuring regulatory compliance.
- Skills: Expertise in quality management software, including Excel, coupled with exceptional communication and organizational abilities.
- Attributes: A proactive, detail-oriented mindset, with the ability to manage multiple priorities and collaborate effectively with diverse teams.
- Education: High school diploma/GED required; bachelor's degree preferred. Quality management or auditing certifications are a plus.
- Physical Capabilities: Ability to meet the physical demands of the role, including standing, lifting (up to 25 lbs), and working with biohazardous materials in a fast-paced setting.
Equal Opportunity Employer: Kamada Plasma is an equal opportunity employer that prohibits discrimination based on race, color, religion, sex, national origin, age, disability, or any other legally protected status. Qualified individuals of all backgrounds are encouraged to apply now and be part of our mission to save lives!
As part of our commitment to a safe workplace, Kamada conducts pre-employment background checks. By applying for a position, you agree to participate in the background check process if selected as a finalist. Results will be kept confidential, and non compliance or negative results may effect employment eligibility.