Talent.com
GRIFOLS, S.A.
Quality Systems AssociateGRIFOLS, S.A. • Memphis, TN, United States
No longer accepting applications
Quality Systems Associate

Quality Systems Associate

GRIFOLS, S.A. • Memphis, TN, United States
5 days ago
Job type
  • Full-time
Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

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 for role (level-specific responsibilities should be included in the chart below):

  • 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. Duties include:
  • 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.
  • 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.
Quality Systems Associate
  • 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. Duties include:
  • 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, the Quality Systems Associate may be required to perform the following duties:
  • Reviews and approves of deferred donor reinstatement activities.
  • Assists with completion of the internal donor center audit.
Summary:
  • 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.


This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

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. 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.

Education:

High school diploma or GED. Obtains state licensures or certifications if applicable.

Experience:

Typically requires no previous related experience.

Occupational Demands Form # 70: 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 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.

#biomatusa

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they 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.

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 : TN-Memphis:USMEMQ - Memphis TN-Quince Rd

Learn more about Grifols
Create a job alert for this search

Quality Systems Associate • Memphis, TN, United States

Similar jobs

Shipping quality coordinator

ABB Holdings IncSenatobia, MS, United States
Full-time

At ABB, we help industries run leaner and cleanerand every person here makes that happen.You'll be empowered to lead, supported to grow, and proud of the impact we create together.Join us and help ... Show more

 • Promoted

Remote M&A Associate - AI Trainer ($50-$60 per hour)

Data AnnotationBartlett, Tennessee
$50.00 hourly
Remote
Full-time +1

DataAnnotation is committed to creating high-quality AI.Join our team to help train the next generation of AI while enjoying the flexibility of remote work and the freedom to set your own&nbsp... Show more

 • Promoted

Fulfillment Center Associate

FedExMillington, CT, US
Full-time +1

Come for a job and stay for a career! Federal Express Corporation (FEC) is part of the rapidly growing warehouse and transportation sector that helps keep America, and our economy, moving.Be part o... Show more

 • Promoted

Laboratory Analyst III

International Flavors and FragrancesMemphis, Tennessee, United States
Full-time

Laboratory Analyst III performs at the entry level under close supervision performing routine tasks in processing or preparing laboratory specimens and material.IFF Nutrition and Biosciences 4272... Show more

 • Promoted

Clinical Director (Home Health)

OptumHERNANDO, Mississippi, United States
Full-time

LHC Group, a leading post-acute care partner for hospitals, physicians and families nationwide.As members of the Optum family of businesses, we are dedicated to helping people feel their best, incl... Show more

 • Promoted

Client Solutions Manager

Slice Merchant ServicesBartlett, TN, US
Full-time

Excellent opportunity to join a leading, national credit card processing company that has over a decade of industry experience.Slice Merchant Services offers innovative payment processing solutions... Show more

 • Promoted

Restaurant Delivery - Receive 100% of Customer Tips

DoorDashHernando, MS, United States

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety o... Show more

 • Promoted

GC Retail Sales Associate Store 722

Guitar Center Stores, Inc.Bartlett, Tennessee, United States
Full-time

Join the Band: Retail Sales Rockstar Wanted!.Are you ready to turn your love for music into a retail experience like no other? We're on the lookout for a new member to join our team of dynamic Sale... Show more

 • Promoted

Software Quality Analyst:: Memphis, TN (REMOTE)

Ark SolutionsMemphis, TN, United States
Remote
Full-time

Software Quality AnalystLocation :Memphis, TN (REMOTE)Duration :monthsWe are seeking a skilled Software Quality Analyst to join our team.This role requires a candidate with a strong background in a... Show more

 • Promoted

61382: Analyst-Revenue Quality

FedEx FreightMemphis, TN, US
Full-time

This position will be domiciled at a FedEx Freight location in Harrison AR or Memphis TN.You will be required to work at a FedEx Freight location several times per week.To provide support for reven... Show more

 • Promoted • New!

Senior Controls Specialist

JobotMemphis, TN, United States
Full-time

Tech Unicorn / Engineering Manager with strong data engineering & cloud experience / 100% remote.This Jobot Job is hosted by: Christine McNamara.Are you a fit? Easy Apply now by clicking the "Apply... Show more

 • Promoted

Remote QGIS Expert

Micro1Hernando, Mississippi, US
$40.00 hourly
Remote
Full-time

Real-world expertise is turned into training data, evaluations, and feedback loops that improve how models perform.AI labs and enterprises use micro1 to train models and build reliable AI agents th... Show more

 • Promoted

Sales Associate

SnipesSenatobia, MS, United States
Part-time

We live sneakers, streetwear, and neighborhood culture! All Day! Every Day!.With more than 750 stores in Europe and the USA, SNIPES is one of the leading sneaker and streetwear retailers worldwide.... Show more

 • Promoted

Quality Manager - Coldwater, MS

FXIColdwater, Mississippi, United States
Full-time

Coldwater, Mississippi, United States.X Facebook LinkedIn Email Copy.Director Reports: 3 Quality Control Lab Technicians.FXI is a leading producer of foam innovation in the Bedding, Furniture, ... Show more

 • Promoted

Cost Basis Associate

Raymond James FinancialMemphis, TN, United States
Full-time

The Cost Basis Associate applies specialized expertise in the securities industry to manage and maintain accurate cost basis, gain/loss, and corporate action data.Utilizing the Cost Basis Reporting... Show more

 • Promoted

QA Engineer

Zealogics.comMemphis, TN, US
Full-time
Quick Apply

Required Skills & Experience Job Description – QA Engineer Publication Management System Role Overview We are seeking a detail-oriented QA Engineer  to ensure the quality, reliabilit... Show more

Project Control Specialist

Acro Service CorpMemphis, TN, United States
Temporary

Title : PROJECT CONTROL SPECIALIST.Location: Memphis TN USA 38109.Duration: 12 months contract with (high possible extension).Develop and implement standard methods for project performance monitori... Show more

 • Promoted

Cath Lab Supervisor

Wheeler Staffing PartnersBartlett, TN, United States
Full-time

This role is responsible for managing both the clinical and administrative functions of the Cath Lab and related diagnostic areas, ensuring high-quality patient care, regulatory compliance, and eff... Show more

 • Promoted

Vision Systems Engineer

Howard IndustriesSouthaven, Mississippi, US
Full-time

As Mississippi's largest privately held employer headquartered within the state, the company employs over 5,000 team members, generates over $1 billion in revenue, and consists of three main corpor... Show more

 • Promoted • New!

Quality Engineer

Lincotek MedicalBartlett, TN, USA
Full-time
Quick Apply

The Quality Engineer is responsible for bringing new products and processes to market on time and within budget, with strong focus on process qualification, product quality, packaging validation, a... Show more