Quality Manager for Plasma Center

Grifols • Pocatello, ID

110d

About The Position

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in more than 110 countries and regions. We are looking for a QUALITY SYSTEMS MANAGER who will evaluate processes, develop action plans, and coordinate the strategic implementation of system processes and corrective actions.

Requirements

• Bachelor of Science degree or equivalent.
• Certified and proficient in quality and compliance.
• Works toward certification from American Society for Quality to be a Certified Quality Auditor.
• Typically requires 2-5 years of related work experience in a medical and/or cGMP regulated environment.
• Experience with plasma or whole blood.

Nice To Haves

• Command of interpersonal communication, organizational and problem-solving abilities.
• Ability to understand and assess FDA regulations.
• Strong integrity and commitment to quality and compliance.
• High level of proficiency with computers.
• Proficient in root cause analysis and corrective/preventative actions.

Responsibilities

• Ensures center compliance with quality standards and regulations.
• Collaborates with Center Managers to ensure product quality, donor suitability, and donor safety.
• Directs and monitors processes and ensures compliance with all applicable regulations.
• Ensures that Standard Operating Procedures (SOPs) are properly interpreted and implemented.
• Oversees internal and external audits, including documentation and implementation of corrective actions.
• Continuously assesses and improves the effectiveness of quality systems in the donor center.
• Responsible for personnel functions of the Quality Systems Associate(s).
• Oversees product and biohazard waste shipments to ensure compliance.
• Documents and investigates deviations and customer complaints.
• Tracks and trends center quality incidents and reports compliance status.
• Ensures accuracy of donor files and compliance with supply quality requirements.
• Directs maintenance and calibration of equipment and documentation.
• Monitors training documents for compliance.
• Prepares quality analysis reports and performs root cause analysis.
• Builds rapport with donors to ensure customer satisfaction.
• Leads projects and initiatives for the region and division.

Benefits

• Comprehensive medical insurance.
• Paid Time Off (PTO).
• Pharmacy benefits.
• Dental and vision insurance.
• Disability insurance.
• Life & AD+D insurance.
• 5% 401K match.
• Tuition reimbursement.
• Opportunities for professional growth and career progression.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree