Biomat USA, Inc. Quality Systems Manager in Penn Hills, Pennsylvania
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Primary Responsibilities for role:
Maintains oversight of the center’s quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.
Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files.
Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained.
Responsible for the personnel functions of the Quality Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks.
Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required.
Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations.
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.
Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness.
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 unit lookback information.
Performs a review of donor adverse event reports and the applicable related documentation.
Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file.
Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance.
Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities.
Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues
Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
Holds monthly Quality Meeting to communicate status updates and manage action outcomes.
EDUCATION AND EXPERIENCE
Bachelor of Science degree or equivalent.
Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood.
Depending on the area of assignment, directly related 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 experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of 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 Form # 6: 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*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Ability to apply abstract principles to solve complex conceptual issues.
We offer benefits including medical, PTO, up to 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!
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols
Req ID: 502393
Type: Regular Full-Time
Job Category: Quality