Grifols
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Quality Systems Associate
role at
Grifols .
We would like to invite you to join an 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 we 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.
Key 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 before use.
Perform documentation review for unsuitable test results.
Assist the Quality Systems Manager to ensure cGMP regulation, SOPs and regulatory requirements are followed.
Perform all product release activities.
Review lookback information and documentation.
Review waste shipment documentation.
Review unexpected plasmapheresis events and related electronic donor chart exceptions during the donation process.
Review electronic donor chart exceptions that impact donor eligibility/safety and/or product quality.
Review donor deferral notifications from competitor centers.
Review plasma processing documentation to ensure 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 documents.
Create, maintain and audit training records and files to ensure compliance.
Perform employee training observations to ensure staff competency before releasing employees to work independently.
Conduct 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.
Assist with completion of the internal donor center audit.
Perform monthly trending report review.
Perform donor adverse events reports review and related documentation.
Conduct training to address donor center corrective and preventive measures.
Additional Responsibilities
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, cGMP, and quality systems. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics and 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 proficiently. Demonstrates good organizational skills and attention to detail. Able to spend hours sitting and reviewing documentation for accuracy.
Education High school diploma or GED. Obtain 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 (protective eyewear, garments, gloves and cold gear). Work is performed mostly while sitting for 4–6 hours per day and standing for 2–4 hours per day. The position requires bending and twisting of the neck, frequent hand movement, precise finger coordination, occasional walking, bending and twisting at waist, and light lifting up to 50 lbs. Requires hearing acuity, color perception, and vision correctable to 20/30 in one eye and 20/100 in the other. Works independently with little guidance and performs a wide range of tasks as dictated by variable demands and changing conditions.
Third Party Agency and Recruiter Notice Agencies that present a candidate to Grifols must have an active, non‑expired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that 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.
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.
Location North America: USA: FL – Gainesville: BTGNS – Gainesville FL‑NW 13th St‑BPC
Seniority Level Entry level
Employment Type Full‑time
Job Function Information Technology
Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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Quality Systems Associate
role at
Grifols .
We would like to invite you to join an 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 we 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.
Key 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 before use.
Perform documentation review for unsuitable test results.
Assist the Quality Systems Manager to ensure cGMP regulation, SOPs and regulatory requirements are followed.
Perform all product release activities.
Review lookback information and documentation.
Review waste shipment documentation.
Review unexpected plasmapheresis events and related electronic donor chart exceptions during the donation process.
Review electronic donor chart exceptions that impact donor eligibility/safety and/or product quality.
Review donor deferral notifications from competitor centers.
Review plasma processing documentation to ensure 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 documents.
Create, maintain and audit training records and files to ensure compliance.
Perform employee training observations to ensure staff competency before releasing employees to work independently.
Conduct 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.
Assist with completion of the internal donor center audit.
Perform monthly trending report review.
Perform donor adverse events reports review and related documentation.
Conduct training to address donor center corrective and preventive measures.
Additional Responsibilities
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, cGMP, and quality systems. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics and 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 proficiently. Demonstrates good organizational skills and attention to detail. Able to spend hours sitting and reviewing documentation for accuracy.
Education High school diploma or GED. Obtain 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 (protective eyewear, garments, gloves and cold gear). Work is performed mostly while sitting for 4–6 hours per day and standing for 2–4 hours per day. The position requires bending and twisting of the neck, frequent hand movement, precise finger coordination, occasional walking, bending and twisting at waist, and light lifting up to 50 lbs. Requires hearing acuity, color perception, and vision correctable to 20/30 in one eye and 20/100 in the other. Works independently with little guidance and performs a wide range of tasks as dictated by variable demands and changing conditions.
Third Party Agency and Recruiter Notice Agencies that present a candidate to Grifols must have an active, non‑expired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that 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.
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.
Location North America: USA: FL – Gainesville: BTGNS – Gainesville FL‑NW 13th St‑BPC
Seniority Level Entry level
Employment Type Full‑time
Job Function Information Technology
Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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