Quality Systems Manager for Plasma Center

Quality Systems Manager for Plasma Center

Location : ID-Pocatello, US

Contract Type : Regular Full-Time

Area : Operations Management

Job Title : Quality Systems Manager

Summary : Evaluates processes, develops action plans, and coordinates the strategic implementation of system processes and corrective actions.

Primary Responsibilities for Role :

• Independent level of quality inspection and control 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 center compliance with all applicable state, federal, and company-designated regulations.
• Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs.
• Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required.
• Oversight of all aspects of internal and external audits including execution (if applicable). This includes documentation, review of and preparation of the response. Also includes implementation of corrective and preventative action, assessment of corrective and preventative actions and follow-up as required.
• Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, direct employee observation and review of center documents.
• Responsible for the personnel functions of the Quality Systems Associate(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all personnel records, management of work schedule and delegation / follow-up of tasks.
• Oversees product and biohazard waste shipments : Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
• Performs a review of the documentation of unsuitable test results and the disposition of the associated results.
• Works in collaboration with the Center Manager to develop the staff's knowledge of their job function and how their performance relates to the end product and patient.
• Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.

Other Responsibilities for Role :

Leads projects and initiatives for the region and division.

Job Requirements : Education :

Experience :

Equivalency :

Depending on the area of assignment, directly related work experience or a combination of directly related education and experience and / or competencies may be considered in place of the stated requirements. Example : If a job level requires a bachelor's degree plus 4 years of experience, an equivalency could include 8 years of work experience, an associate degree with 6 years of work experience, or a master's degree with 2 years of work experience.

Knowledge, Skills & Abilities :

Command of interpersonal communication, organizational and problem-solving abilities. Ability to understand and assess FDA regulations. Strong integrity and commitment to quality and compliance. Full command of mathematics. Legible handwriting. High level of proficiency with computers. Proficient in root cause analysis and corrective / preventative actions. Ability to balance multiple competing priorities. Strong time management abilities. Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team. Ability to work with minimal supervision. Ability to travel when needed for meetings, events, and occasional support of other centers.

Occupational Demands :

Work is performed in an office and / or a laboratory / manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32

Benefits :

We offer a comprehensive package of benefits including medical, Paid Time Off (PTO), pharmacy, dental, vision, disability insurance, life & AD+D insurance, 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years we're growing, and you can grow with us!