Quality Systems Associate

GRIFOLS, S.A. • Houston, TX

3d • Onsite

About The Position

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. This role involves completing weekly reviews of equipment QC and maintenance records, documenting, investigating, and performing root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety. The associate will inspect and release incoming supplies, investigate and report supplies that have not met quality specifications and requirements prior to use, and perform documentation review for unsuitable test results. Additionally, the role assists the Quality Systems Manager in ensuring cGMP regulation, SOPs and regulatory requirements are followed, including performing all product release activities, reviewing lookback information and documentation, waste shipment documentation, unexpected plasmapheresis events, 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. The associate also assists the Quality Systems Manager in ensuring center training programs follow procedural requirements, which includes creating, maintaining, and auditing training records and files, performing employee training observations to ensure staff competency, and conducting 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, the Quality Systems Associate may be required to review and approve deferred donor reinstatement activities and assist with the completion of the internal donor center audit. The role also performs review of monthly trending reports, donor adverse events reports and applicable related documentation, and conducts training to address donor center corrective and preventative measures. This job description is intended to present the general content and requirements for the performance of this job and is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Requirements

• 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.
• 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.
• High school diploma or GED.
• Obtains state licensures or certifications if applicable.
• Typically requires no previous related experience.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office and laboratory equipment.
• Exposure to extreme cold below 32 degrees F 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.
• The position does require bending and twisting of neck up from 2 to 4 hours per day.
• Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.
• Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects.
• Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion.
• Occasionally walks, bends and twists at waist.
• Light lifting of 15lbs. with a maximum lift of 50lbs.
• 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.

Nice To Haves

• Developing command of interpersonal communication, organizational and problem-solving skills.

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 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 the proper freezing, storage and handling of product.
• 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.
• Reviews and approves of deferred donor reinstatement activities (when Quality Systems Manager is absent).
• Assists with completion of the internal donor center audit (when Quality Systems Manager is absent).
• 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.
• Is certified and maintains certification as a Donor Center Technician.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED