Join us at Grifols, a global leader in plasma-derived medicines, and help enhance the lives of millions! As a Quality Systems Manager, you will play a crucial role in ensuring the quality and safety of our products while collaborating with a dedicated team committed to excellence in healthcare.
JOB TITLE: MANAGER OF QUALITY SYSTEMS
ESTIMATED SALARY RANGE: $61K - $92K per year, depending on training, education, and experience. This position is also eligible for up to 20% of the company bonus pool.
SIGNING BONUS: $5K payable in two installments: 30% at 6 months and 70% at one year.
Summary: You will evaluate processes, develop action plans, and strategically implement system processes and corrective actions to maintain high standards of quality.
Primary Responsibilities:
- Ensure compliance with quality standards and regulations through independent quality inspection and control.
- Collaborate with Center Managers to safeguard product quality, donor suitability, and donor safety.
- Direct and monitor processes to ensure compliance with state, federal, and company regulations.
- Interpret and implement Standard Operating Procedures (SOPs) effectively while providing staff training.
- Oversee internal and external audits, including documentation and corrective actions.
- Continuously improve the effectiveness of quality systems through trend analysis and investigations.
- Manage the Quality Systems Associate(s) by directing work, training, and maintaining personnel records.
- Ensure regulatory compliance in product and biohazard waste shipments.
- Document and analyze deviations and complaints to protect donor safety and product quality.
- Enhance staff knowledge of roles in relation to product quality and safety.
Other Responsibilities:
- Track center quality incidents and report compliance status.
- Ensure accuracy of donor records and quality of supplies.
- Direct equipment maintenance and compliance documentation.
- Monitor documentation of proficiency tests and training.
- Conduct quality control checks as required.
- Prepare quality analysis reports and lead systemic compliance initiatives.
- Foster relationships with donors to ensure satisfaction and long-term donation.
Job Requirements:
EDUCATION:
- Bachelor of Science degree or equivalent.
- Certified in quality and compliance.
- Working toward certification as a Certified Quality Auditor or Designated Trainer.
EXPERIENCE:
- 2-5 years of experience in a medical or cGMP regulated environment.
- Experience with plasma or whole blood is preferred.
KNOWLEDGE, SKILLS & ABILITIES: Strong communication, problem-solving, and organizational skills are essential. Familiarity with FDA regulations and quality compliance is required. Proficiency in root cause analysis and corrective/preventative actions is crucial, along with effective time management and the ability to handle multiple priorities.
OCCUPATIONAL DEMANDS: Work will be performed in an office and/or laboratory setting, involving exposure to biological materials, electrical equipment, and the potential for physical activities such as lifting up to 35 lbs. Personal protective equipment will be used as required.
LOCATION: 1901 W 8th Ave, Eugene, OR 97402
At Grifols, we offer a comprehensive benefits package, including medical and dental insurance, paid time off, a 401K match, and opportunities for professional growth in a family-like culture.