Grifols Shared Services North America, Inc Quality Specialist I in San Marcos, Texas
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Responsible for ensuring compliance with applicable domestic and international standards and regulation through audits and systematic maintenance of effective quality systems. Ensures that deadlines are met on time and within budget. Limited interface with other departments and business or marketing partners. Work independently with supervision and exercise judgment within the defined procedures and practices to determine appropriate actions.
Primary responsibilities for role:
Perform daily donor record file review.
Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual.
Perform a review of donor center records.
Perform weekly review of equipment incident logs.
Verification and release of sample shipment.
Perform Staging of plasma for shipment.
Inspection and release of incoming supplies.
Perform Weekly employee observations.
Participate in the Quality Assurance meetings and be part of the Quality Assurance team.
Assist the Center Quality Manager to ensure that cGMP regulations are followed.
Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met.
Performs a review of the documentation of unsuitable test results and the disposition of the associated units.
On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties:
Performs all product release activities.
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.
Review of equipment records and DMS information if applicable to approve out of service machines for use.
Review and approval of deferred donor reinstatement activities.
Perform a review of lookback information
Waste shipment review
Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use.
Perform a review of medical incident reports and the applicable related documentation.
Knowledge, Skills, and Abilities:
Basic understanding of QSR & ISO requirements
Basic knowledge of QC, Manufacturing & Inventory Processes
Knowledge of Microsoft Word, Excel, Power Point and related functions including the formulation of graphs.
Organizational skills, attention to detail and ability to prioritize in fast paced environment is essential
Must demonstrate initiative, balanced assertiveness, flexibility and team orientation
High school and 6+ years related experience or
AA and 4+ years related experience or BS and 2-4 years related experience
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.
- May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.
EEO Minorities/ Disability/Veterans
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. 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.
Learn more about Grifols (http://www.grifols.com/es/web/international/home)
Req ID: 501800
Type: Regular Full-Time
Job Category: Quality