Grifols
Quality Systems Associate
Join Grifols' international team working to improve the future of healthcare. Grifols is a global healthcare company that has been working to improve the health and well‑being of people around the world since 1909. 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.
Summary Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol.
Responsibilities
Completes weekly review of equipment QC and maintenance records.
Documents, investigates, and performs root‑cause analysis for deviations and customer complaints 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, including all product release activities.
Reviews look‑back information and documentation.
Reviews waste shipment documentation.
Reviews unexpected plasmapheresis events and related electronic donor chart exceptions.
Reviews donor deferral notifications from competitor centers.
Reviews plasma processing documentation to ensure proper freezing, storage and handling of product.
Performs review of monthly trending reports and donor adverse event reports.
Conducts training to address donor center corrective and preventative measures.
Additional Responsibilities
Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in donor center SOPs and/or training program documents.
Creates, maintains, and audits training records and files to ensure compliance.
Performs employee training observations to ensure staff competency before releasing employees to work independently.
Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
When the Quality Systems Manager is absent, reviews and approves deferred donor reinstatement activities and assists with completion of the internal donor center audit.
Is certified and maintains certification as a Donor Center Technician.
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; performs basic document review and employee observations; communicates openly with the CQM on issues noted during reviews; understands and follows SOPs and protocols; performs primary responsibilities of the Quality Associate role in a proficient manner; basic understanding of cGMP and quality systems; spent hours reviewing documentation for accuracy; demonstrates good organizational skills and attention to detail.
Education High school diploma or GED. Obtains state licensures or certifications if applicable.
Experience Typically requires no previous related experience.
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°F while performing reviews in plasma freezers; personal protective equipment required such as protective eyewear, garments, gloves and cold‑gear. Work mostly while sitting (4–6 hours per day) and standing (2–4 hours per day). Requires bending, twisting, frequent hand and foot movements, light lifting (up to 50 lbs) and precise coordination; hearing and vision requirements as described. Works independently with little guidance.
Equal Employment Opportunity 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.
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. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Location NORTH AMERICA : USA : TX-San Antonio:BTSAT - San Antonio TX-NW Loop 410-BPC
Seniority Level: Entry level
Employment type: Full-time
Job function: Information Technology
Industries: Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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Summary Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol.
Responsibilities
Completes weekly review of equipment QC and maintenance records.
Documents, investigates, and performs root‑cause analysis for deviations and customer complaints 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, including all product release activities.
Reviews look‑back information and documentation.
Reviews waste shipment documentation.
Reviews unexpected plasmapheresis events and related electronic donor chart exceptions.
Reviews donor deferral notifications from competitor centers.
Reviews plasma processing documentation to ensure proper freezing, storage and handling of product.
Performs review of monthly trending reports and donor adverse event reports.
Conducts training to address donor center corrective and preventative measures.
Additional Responsibilities
Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in donor center SOPs and/or training program documents.
Creates, maintains, and audits training records and files to ensure compliance.
Performs employee training observations to ensure staff competency before releasing employees to work independently.
Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
When the Quality Systems Manager is absent, reviews and approves deferred donor reinstatement activities and assists with completion of the internal donor center audit.
Is certified and maintains certification as a Donor Center Technician.
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; performs basic document review and employee observations; communicates openly with the CQM on issues noted during reviews; understands and follows SOPs and protocols; performs primary responsibilities of the Quality Associate role in a proficient manner; basic understanding of cGMP and quality systems; spent hours reviewing documentation for accuracy; demonstrates good organizational skills and attention to detail.
Education High school diploma or GED. Obtains state licensures or certifications if applicable.
Experience Typically requires no previous related experience.
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°F while performing reviews in plasma freezers; personal protective equipment required such as protective eyewear, garments, gloves and cold‑gear. Work mostly while sitting (4–6 hours per day) and standing (2–4 hours per day). Requires bending, twisting, frequent hand and foot movements, light lifting (up to 50 lbs) and precise coordination; hearing and vision requirements as described. Works independently with little guidance.
Equal Employment Opportunity 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.
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. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Location NORTH AMERICA : USA : TX-San Antonio:BTSAT - San Antonio TX-NW Loop 410-BPC
Seniority Level: Entry level
Employment type: Full-time
Job function: Information Technology
Industries: Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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