Grifols
Quality Systems Associate
role at
Grifols
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 worldwide. We are leaders in plasma‑derived medicines and transfusion medicine, developing, producing and marketing innovative medicines, solutions and services in more than 110 countries and regions.
Pay scale:
$23.46–31.74 per hour, eligible to participate in up to 4% of the company bonus pool. Benefits include medical, paid time off, up to 5% 401(k) match, and tuition reimbursement. Grifols offers opportunities for professional growth and career progression within a family‑like culture.
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 protocols.
Primary Responsibilities
Complete weekly review of equipment QC and maintenance records.
Document, investigate, and perform root‑cause analysis for deviations and customer complaints related to product quality and/or donor safety.
Inspect and release incoming supplies; investigate and report supplies that do not meet quality specifications prior to use.
Perform documentation review for unsuitable test results.
Assist the Quality Systems Manager to ensure that cGMP regulations, SOPs and regulatory requirements are followed, including all product release activities, lookback information review, waste shipment documentation and unexpected plasmapheresis events.
Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality, donor deferral notifications from competitor centers, and plasma processing documentation to ensure proper freezing, storage and handling of product.
Assist the Quality Systems Manager with training programs, creating and maintaining training records, performing employee training observations, and conducting required training activities for center notifications, corporate directives, SOP changes and initial SOP implementations.
When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with completion of the internal donor center audit.
Perform review of monthly trending reports and donor adverse events reports, and conduct training to address donor center corrective and preventative measures.
Additional Responsibilities
Certified as a Donor Center Technician and maintain certification.
Knowledge, Skills, and Abilities
Proficiency with computers.
Strong integrity and commitment to quality and compliance.
Knowledge of FDA regulations and ability to understand and follow SOPs and protocols.
Organizational, problem‑solving and interpersonal communication skills.
Basic understanding of cGMP and quality systems.
Attention to detail and ability to spend hours reviewing documentation for accuracy.
Education
High school diploma or GED; state licensures or certifications as applicable.
Experience
Typically requires no previous related experience.
Occupational Demands
Work performed in a plasma center with exposure to biological fluids.
Exposure to electrical office and laboratory equipment and extreme cold below 32°F during reviews in plasma freezers.
Requires bending, twisting, and frequent hand movements; light lifting up to 15 lbs, occasional lifting up to 50 lbs.
Requires wearing protective eyewear, garments, gloves and cold gear.
Ability to communicate information and ideas to diverse groups and work independently with little guidance.
Location Chicago, IL (North America: USA: IL-Chicago)
Equity and Inclusive Hiring 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, protected veteran status, or disability. We will consider all qualified applicants in a manner consistent with applicable law.
Seniority Level
Entry level
Employment Type
Full‑time
Job Function
Information Technology
Industries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
#J-18808-Ljbffr
role at
Grifols
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 worldwide. We are leaders in plasma‑derived medicines and transfusion medicine, developing, producing and marketing innovative medicines, solutions and services in more than 110 countries and regions.
Pay scale:
$23.46–31.74 per hour, eligible to participate in up to 4% of the company bonus pool. Benefits include medical, paid time off, up to 5% 401(k) match, and tuition reimbursement. Grifols offers opportunities for professional growth and career progression within a family‑like culture.
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 protocols.
Primary Responsibilities
Complete weekly review of equipment QC and maintenance records.
Document, investigate, and perform root‑cause analysis for deviations and customer complaints related to product quality and/or donor safety.
Inspect and release incoming supplies; investigate and report supplies that do not meet quality specifications prior to use.
Perform documentation review for unsuitable test results.
Assist the Quality Systems Manager to ensure that cGMP regulations, SOPs and regulatory requirements are followed, including all product release activities, lookback information review, waste shipment documentation and unexpected plasmapheresis events.
Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality, donor deferral notifications from competitor centers, and plasma processing documentation to ensure proper freezing, storage and handling of product.
Assist the Quality Systems Manager with training programs, creating and maintaining training records, performing employee training observations, and conducting required training activities for center notifications, corporate directives, SOP changes and initial SOP implementations.
When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with completion of the internal donor center audit.
Perform review of monthly trending reports and donor adverse events reports, and conduct training to address donor center corrective and preventative measures.
Additional Responsibilities
Certified as a Donor Center Technician and maintain certification.
Knowledge, Skills, and Abilities
Proficiency with computers.
Strong integrity and commitment to quality and compliance.
Knowledge of FDA regulations and ability to understand and follow SOPs and protocols.
Organizational, problem‑solving and interpersonal communication skills.
Basic understanding of cGMP and quality systems.
Attention to detail and ability to spend hours reviewing documentation for accuracy.
Education
High school diploma or GED; state licensures or certifications as applicable.
Experience
Typically requires no previous related experience.
Occupational Demands
Work performed in a plasma center with exposure to biological fluids.
Exposure to electrical office and laboratory equipment and extreme cold below 32°F during reviews in plasma freezers.
Requires bending, twisting, and frequent hand movements; light lifting up to 15 lbs, occasional lifting up to 50 lbs.
Requires wearing protective eyewear, garments, gloves and cold gear.
Ability to communicate information and ideas to diverse groups and work independently with little guidance.
Location Chicago, IL (North America: USA: IL-Chicago)
Equity and Inclusive Hiring 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, protected veteran status, or disability. We will consider all qualified applicants in a manner consistent with applicable law.
Seniority Level
Entry level
Employment Type
Full‑time
Job Function
Information Technology
Industries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
#J-18808-Ljbffr