Quality Systems Associate

4 weeks ago

AZMesa, United States GRIFOLS, S.A. Full time

table.MiTabla { max-width: 1020px;important

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

 

 

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:

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.

 

CLK789

#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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws

 

Location: NORTH AMERICA : USA : AZ-Mesa:USMESA - Mesa AZ-S Dobson Rd-BIO 

 

Learn more about Grifols

 

  • Quality Technician

    2 weeks ago

    Mesa, United States Nammo Defense Systems, Inc Full time

    Position Summary: As a Quality Technician, you will be performing in-process and final inspection on manufactured assemblies to ensure compliance to blueprints and specifications as required by the manufacturing working instructions. Quality Technicians at Nammo Defense Systems are responsible for conducting visual and dimensional inspections using standard...

  • Security System Installation Technician

    3 months ago

    Mesa, United States Technical Systems Inc Full time

    Job DescriptionJob DescriptionTechnical Systems is hiring an Security System Installation Technician to service our clients throughout the region. Our demand is rapidly growing, and we are looking for amazing people to join our team. This opportunity has tremendous potential for rapid growth within the company for the right individual. Our ideal candidate...

  • Aerospace Quality Inspector

    2 weeks ago

    Mesa, Arizona, United States STS Aviation Group Full time

    STS Aviation Group is seeking skilled Aerospace Quality Inspectors to join our dynamic team.Position Overview:The Aerospace Quality Inspector is responsible for evaluating and ensuring the airworthiness of aircraft, systems, equipment, and components in accordance with established specifications and regulatory standards. This role involves conducting...

  • Aviation Systems Specialist

    5 days ago

    Mesa, Arizona, United States Aviation Technology Associates, LLC Full time

    Job Summary: Aviation Technology Associates, LLC is seeking a highly skilled Avionics/Electrical Technician II to join our team. As a key member of our maintenance team, you will be responsible for providing technical expertise in testing aircraft systems, troubleshooting and repairing system discrepancies to ensure minimum schedule impact. Key...

  • Supplier Quality Engineer

    2 months ago

    Mesa, United States FUJIFILM Corporation Full time

    Overview: Who We Are FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our Mesa, Arizona facility for a Supplier Quality Engineer! With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea...

  • Quality Assurance Specialist

    1 week ago

    Mesa, Arizona, United States Amphenol Borisch Technologies Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Amphenol Borisch Technologies. As a Quality Assurance Specialist, you will play a vital role in ensuring customer requirements are met through the purchasing, inspection, and launching of products.Key Responsibilities:Collaborate with Quality Engineers to identify...

  • Quality Manager

    3 months ago

    Mesa, United States KP AVIATION LLC Full time

    Job DescriptionJob DescriptionDescription:KP Aviation, an international supplier and procurer of aftermarket aviation components and assets, is searching for the next key member of our team! Quality Manager is responsible for training, maintaining, and updating quality certifications, supporting corrective actions, developing, and communicating quality...

  • Quality Manager

    3 months ago

    Mesa, United States KP Aviation, LLC Full time

    Job DescriptionJob DescriptionKP Aviation, an international supplier and procurer of aftermarket aviation components and assets, is searching for the next key member of our team! Quality Manager is responsible for training, maintaining, and updating quality certifications, supporting corrective actions, developing, and communicating quality goals,...

  • Director of Quality

    3 weeks ago

    Mesa, United States KP AVIATION LLC Full time

    Job DescriptionJob DescriptionDescription:KP Aviation, an international supplier and procurer of aftermarket aviation components and assets, is searching for the next key member of our team! Director of Quality is responsible for training, maintaining, and updating quality certifications, supporting corrective actions, developing, and communicating quality...

  • Quality Control Systems Account Executive

    2 weeks ago

    La Mesa, California, United States Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob OverviewWhat impact will you have?As an Account Manager in the Production Process and Analytics (PPA) division of the Chemical Analysis sector at Thermo Fisher Scientific Inc., you will be integral to our sales and commercial initiatives. By spearheading the sales and account management for...

  • Quality Control Systems Account Executive

    1 week ago

    La Mesa, California, United States Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob OverviewWhat impact will you create?As an Account Executive within the Production Process and Analytics (PPA) sector of the Chemical Analysis Division (CAD) at Thermo Fisher Scientific Inc., you will be instrumental in driving our sales and commercial initiatives. By spearheading the sales and...

  • Quality Control Systems Account Executive

    1 week ago

    La Mesa, California, United States Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob OverviewHow will you contribute to our success?As an Account Executive within the Production Process and Analytics (PPA) division of the Chemical Analysis sector at Thermo Fisher Scientific Inc., you will be instrumental in our sales and commercial strategies. By spearheading the sales and...

  • Quality Control Systems Account Executive

    1 week ago

    La Mesa, California, United States Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob OverviewWhat impact will you have?As an Account Manager in the Production Process and Analytics (PPA) division of the Chemical Analysis Sector at Thermo Fisher Scientific Inc., you will be instrumental in driving our sales and commercial initiatives. By spearheading the sales and account...

  • Quality Control Systems Account Executive

    1 week ago

    La Mesa, California, United States Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob OverviewWhat impact will you have?As an Account Manager in the Production Process and Analytics (PPA) division of the Chemical Analysis Division (CAD) at Thermo Fisher Scientific Inc., you will be instrumental in our sales and commercial initiatives. By spearheading the sales and account...

  • Quality Control Systems Account Executive

    1 week ago

    La Mesa, California, United States Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob OverviewWhat impact will you have?As an Account Executive within the Production Process and Analytics (PPA) division of the Chemical Analysis sector at Thermo Fisher Scientific Inc., you will be integral to our sales and commercial initiatives. By spearheading the sales and account management...

  • Quality Technician

    3 weeks ago

    Mesa, United States Nammo Defense System Full time

    Job DescriptionJob DescriptionPosition Summary: As a Quality Technician, you will be performing in-process and final inspection on manufactured assemblies to ensure compliance to blueprints and specifications as required by the manufacturing working instructions. Quality Technicians at Nammo Defense Systems are responsible for conducting visual and...

  • Quality Assurance Engineer

    2 weeks ago

    Costa Mesa, California, United States Anduril Industries Full time

    Company Overview: Anduril Industries is a pioneering defense technology firm dedicated to enhancing U.S. and allied military capabilities through innovative technology. Mission: By integrating the expertise and business models of the most forward-thinking companies of the 21st century into the defense sector, Anduril is revolutionizing the design,...

  • Manufacturing Systems Technician

    2 weeks ago

    Mesa, Arizona, United States Express Employment Professionals Full time

    Job OverviewPosition Title: Manufacturing Systems TechnicianEmployment Type: Full-TimeRole Summary:We are looking for a proficient Manufacturing Systems Technician to enhance our production operations. The successful candidate will possess expertise in assessing, diagnosing, and resolving challenges within automated manufacturing systems. A solid foundation...

  • Quality Engineer

    2 months ago

    Mesa, United States Magna International Inc. Full time

    #jobreq_print_container div { line-height: 14px; } #jobreq_print_container div span { font-size: 12px; } About us We see a future where everyone can live and move without limitations. That’s why we are developing technologies, systems and concepts that make vehicles safer and cleaner, while serving our communities, the planet and, above all,...

  • Quality Supervisor

    3 weeks ago

    Mesa, Arizona, United States Magna International Inc. Full time

    About usWe see a future where everyone can live and move without limitations. That's why we are developing technologies, systems and concepts that make vehicles safer and cleaner, while serving our communities, the planet and, above all, people. Forward. For all. Group SummaryAs an engineering and manufacturing partner, Magna's Complete Vehicle group helps...