Grifols, S.A
Overview
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. Responsibilities
Completes weekly review of equipment QC and maintenance records. Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety. Inspects and releases incoming supplies. Investigates and reports supplies that have not met quality specifications and requirements prior to use. Performs documentation review for unsuitable test results. Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Performs all product release activities. Reviews lookback information and documentation. Reviews waste shipment documentation. Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process. Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality. Reviews donor deferral notifications from competitor centers. Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product. Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents. Creates, maintains, and audits training records and files to ensure compliance. Performs employee training observations to ensure staff competency prior to releasing employees to work independently. Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations. On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties: Reviews and approves of deferred donor reinstatement activities. Assists with completion of the internal donor center audit. Performs review of monthly trending report. Performs review of donor adverse events reports and the applicable related documentation. Conducts training to address donor center corrective and preventative measures. Education & Experience
High school diploma or GED. Obtains state licensures or certifications if applicable. Typically requires no previous related experience. Knowledge, Skills, and Abilities
Developing command of interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Occupational Demands
Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Equal Opportunity Statement
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location
North America : USA : TX-Houston:USLYORK - Houston TX-W Little York-BIO
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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. Responsibilities
Completes weekly review of equipment QC and maintenance records. Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety. Inspects and releases incoming supplies. Investigates and reports supplies that have not met quality specifications and requirements prior to use. Performs documentation review for unsuitable test results. Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Performs all product release activities. Reviews lookback information and documentation. Reviews waste shipment documentation. Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process. Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality. Reviews donor deferral notifications from competitor centers. Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product. Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents. Creates, maintains, and audits training records and files to ensure compliance. Performs employee training observations to ensure staff competency prior to releasing employees to work independently. Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations. On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties: Reviews and approves of deferred donor reinstatement activities. Assists with completion of the internal donor center audit. Performs review of monthly trending report. Performs review of donor adverse events reports and the applicable related documentation. Conducts training to address donor center corrective and preventative measures. Education & Experience
High school diploma or GED. Obtains state licensures or certifications if applicable. Typically requires no previous related experience. Knowledge, Skills, and Abilities
Developing command of interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Occupational Demands
Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Equal Opportunity Statement
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location
North America : USA : TX-Houston:USLYORK - Houston TX-W Little York-BIO
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