Grifols
Quality Systems Associate
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
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 donor safety.
Inspect and release incoming supplies, and investigate reports of supplies that have not met quality specifications and requirements 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:
Perform all product release activities.
Review lookback information and documentation.
Review waste shipment documentation.
Review unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions during the donation process.
Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
Review donor deferral notifications from competitor centers.
Review plasma processing documentation to ensure the proper freezing, storage and handling of product.
Perform all product release activities.
Additional Responsibilities
Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training program documents.
Create, maintain, and audit training records and files to ensure compliance.
Perform employee training observations to ensure staff competency prior to 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, perform the following duties:
Review and approve deferred donor reinstatement activities.
Assist with completion of the internal donor center audit.
Is certified and maintains certification as a Donor Center Technician.
Summary of Key Activities
Perform review of monthly trending report.
Perform review of donor adverse events reports and the applicable related documentation.
Conduct training to address donor center corrective and preventative measures.
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.
Ability to understand and follow SOP’s and protocols.
Perform primary responsibilities of the Quality Associate role in a proficient manner.
Basic understanding of cGMP and quality systems.
Ability 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 is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms, electrical office and laboratory equipment, and extreme cold below 32 degrees Fahrenheit 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. Requires bending and twisting of neck for 2 to 4 hours per day, frequent hand movement, ability to perform precise coordinated movements of the fingers to grasp and manipulate objects, frequent foot movement, occasional walking, bending and twisting at waist. Light lifting of 15 lbs with a maximum lift of 50 lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.
Location NORTH AMERICA : USA : TX-Channelview:USCHANNE - Channelview TX-Sheldon Rd-BPL
Equal Employment 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.
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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 donor safety.
Inspect and release incoming supplies, and investigate reports of supplies that have not met quality specifications and requirements 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:
Perform all product release activities.
Review lookback information and documentation.
Review waste shipment documentation.
Review unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions during the donation process.
Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
Review donor deferral notifications from competitor centers.
Review plasma processing documentation to ensure the proper freezing, storage and handling of product.
Perform all product release activities.
Additional Responsibilities
Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training program documents.
Create, maintain, and audit training records and files to ensure compliance.
Perform employee training observations to ensure staff competency prior to 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, perform the following duties:
Review and approve deferred donor reinstatement activities.
Assist with completion of the internal donor center audit.
Is certified and maintains certification as a Donor Center Technician.
Summary of Key Activities
Perform review of monthly trending report.
Perform review of donor adverse events reports and the applicable related documentation.
Conduct training to address donor center corrective and preventative measures.
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.
Ability to understand and follow SOP’s and protocols.
Perform primary responsibilities of the Quality Associate role in a proficient manner.
Basic understanding of cGMP and quality systems.
Ability 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 is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms, electrical office and laboratory equipment, and extreme cold below 32 degrees Fahrenheit 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. Requires bending and twisting of neck for 2 to 4 hours per day, frequent hand movement, ability to perform precise coordinated movements of the fingers to grasp and manipulate objects, frequent foot movement, occasional walking, bending and twisting at waist. Light lifting of 15 lbs with a maximum lift of 50 lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.
Location NORTH AMERICA : USA : TX-Channelview:USCHANNE - Channelview TX-Sheldon Rd-BPL
Equal Employment 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.
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