Grifols
Quality Systems Associate
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.
Primary 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 proper freezing, storage and handling of product.
Training and Audit Responsibilities
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, perform reviews and approvals of deferred donor reinstatement activities and assist with completion of the internal donor center audit.
Additional Responsibilities
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.
Qualifications
Certified as a Donor Center Technician and maintains certification.
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.
Ability to understand and follow SOPs and protocols.
Ability to perform primary responsibilities of the Quality Associate role in a proficient manner.
Has a basic understanding of cGMP and quality systems.
Is able to spend hours sitting and 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 performed in a plasma center. Exposure to biological fluids, electrical equipment, and extreme cold conditions. Requires standing, bending, hand movements, and light lifting up to 50 lb. Good vision and hearing are required.
Location North America : USA : WI‑Madison: IBMADVER - Madison WI-Verona Rd-IBBI
Seniority Level Entry level
Employment Type Full‑time
Job Function Information Technology
Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing
EEO Statement Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices, national origin, pregnancy, childbirth, related medical conditions, protected veteran status, or disability. All qualified applicants will be considered for employment in a manner consistent with applicable laws.
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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.
Primary 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 proper freezing, storage and handling of product.
Training and Audit Responsibilities
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, perform reviews and approvals of deferred donor reinstatement activities and assist with completion of the internal donor center audit.
Additional Responsibilities
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.
Qualifications
Certified as a Donor Center Technician and maintains certification.
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.
Ability to understand and follow SOPs and protocols.
Ability to perform primary responsibilities of the Quality Associate role in a proficient manner.
Has a basic understanding of cGMP and quality systems.
Is able to spend hours sitting and 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 performed in a plasma center. Exposure to biological fluids, electrical equipment, and extreme cold conditions. Requires standing, bending, hand movements, and light lifting up to 50 lb. Good vision and hearing are required.
Location North America : USA : WI‑Madison: IBMADVER - Madison WI-Verona Rd-IBBI
Seniority Level Entry level
Employment Type Full‑time
Job Function Information Technology
Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing
EEO Statement Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices, national origin, pregnancy, childbirth, related medical conditions, protected veteran status, or disability. All qualified applicants will be considered for employment in a manner consistent with applicable laws.
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