- You will report to the Associate Director, Quality
- Ensure the center is "inspection ready" by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system.
- Manage the Quality Control program, calibrations management, monitor of compliance to defined processes e.g. sampling, competency checks, trending and analysis of Indicators, cause and failure mode impact assessment and change management.
- You will recruit, hire, conduct performance reviews, lead investigations and deviations, enact corrective actions, and termination.
- Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA), federal, state and local regulatory, company procedures.
- Follow all HR practices through fair treatment of all employees.
- Monitor CAPA's and effectiveness checks to ensure issues are resolved.
- Overnight travel required up to 10% of the time.
Education
- Bachelor's degree in scientific discipline/life sciences or related discipline preferred OR equivalent combination of education and professional work experience required
Experience
- 5+ years' experience related to quality and regulatory/ Plasma industry experience
- 1 year supervisory, leadership experience responsible for overseeing the activities of others
- 1year Quality experience (CSA/CSAb) required
- Completion of CSL Plasma Leadership Development program
Additional Comments
- Maintain company Technical Training certification
- Knowledge of complex government and industry regulations, and ability to monitor compliance with these regulations
- Manage entire financial responsibility of the center
- Proficient in English
Working Conditions
- Exposure to hazardous chemicals, extreme temperatures and to bloodborne pathogens.
- Required to wear Personal Protective Equipment while performing tasks or in certain areas
Benefits
CSL offers the following benefits: medical/dental/vision benefits, Short- and Long-term disability, tuition assistance, 401K, 15 days of PTO, 4 personal holidays + 8 company holidays/year.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classification.
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Company DescriptionSupported by parent company CSL Behring, the global leader in plasma protein biotherapeutics, CSL Plasma has more than 300 plasma collection centers globally. CSL Plasma also has a state-of-the-art testing laboratory that features some of the most advanced technology, instrumentation and automation in the field; two logistics centers, one in Dallas and one in Indianapolis. Our corporate headquarters is in Boca Raton, Florida.Our U.S. plasma collection centers are committed to the highest standards of quality and safety. When you donate, you give a valuable gift to those who require plasma-derived therapies to live healthier lives.
The CSL Group has a combined heritage of outstanding contribution to medicine and human health with more than 100 years’ experience in the development and manufacture of vaccines and plasma protein biotherapies.
With major facilities in Australia, Germany, Switzerland and the US, CSL has over 30,000 employees working in 100 countries.