Quality System Manager

2 weeks ago

WinstonSalem, North Carolina, United States Grifols Careers Full time

Would you like to join an international team working to improve the future of healthcare? 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.

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.

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.

Ensures shipments meet regulatory specifications and product release requirements; Performs a review of the documentation of unsuitable test results and unit lookback information.

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.

Determines donor suitability activities and manages donor deferrals as appropriate. 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.

Bachelor of Science degree or equivalent.
Typically requires 2 years of related experience in a medical and/or cGMP regulated environment

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.

Strong integrity and commitment to quality and compliance. High level of proficiency with computers. Proficient in root cause analysis and corrective/preventative actions. 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 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 drives to site locations with occasional travel within the United States. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement.

Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture.

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Third Party Agency and

Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.

We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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