Quality Systems Associate

3 weeks ago

OHAkron, 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

 

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:

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 : OH-Akron:USNC0805 - Akron 

 

Learn more about Grifols

 

  • Associate Scientist

    1 week ago

    Akron, Ohio, United States Artech LLC Full time

    Position: Associate Scientist - Quality Assurance SpecialistLocation: Summit, NJWork Schedule: Wed-Sat (7am-5pm) ESTQualifications Required: Bachelor's Degree in a relevant field such as Science or Engineering, preferably in Biochemistry or life sciences (advanced degree is a plus). At least 1 year of pertinent experience in a regulated environment....

  • Associate Scientist

    1 week ago

    Akron, Ohio, United States Artech LLC Full time

    Position Title: Associate Scientist - Quality Assurance SpecialistLocation: Summit, NJWork Schedule: Wednesday to Saturday (7am-5pm) ESTEssential Qualifications: A Bachelor's Degree in a relevant field such as Science or Engineering, preferably in Biochemistry or life sciences (advanced degree is a plus). At least 1 year of pertinent experience in a...

  • Quality Systems Manager

    2 weeks ago

    OH-Toledo, 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...

  • Associate Director, Quality Product Lead

    3 weeks ago

    Akron, Ohio, United States Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Quality Assurance Manager

    5 days ago

    Akron, Ohio, United States Structural Integrity Associates, Inc. Full time

    Job DescriptionStructural Integrity Associates, Inc. is seeking a highly motivated and experienced Quality Assurance Manager to join our team. The purpose of this role is to provide a full range of quality activities in direct support of the company's business and support teams across the enterprise, including responsibility for a Nuclear Quality Assurance...

  • Quality Assurance Manager

    4 days ago

    Akron, Ohio, United States Structural Integrity Associates, Inc. Full time

    Job DescriptionStructural Integrity Associates, Inc. is seeking a highly motivated and experienced Quality Assurance Manager to join our team. The purpose of this role is to provide a full range of quality activities in direct support of the company's business and support teams across the enterprise, including responsibility for a Nuclear Quality Assurance...

  • Quality Technician

    3 days ago

    Akron, United States S&A Industries Corporation Full time

    General Description: This position is responsible for general support of the Quality department including but not limited to Inspections, receiving Inspections, Lab testing, Quality Alerts and First/Last off procedures. *Responsibilities: * Communicate quality concerns with urgency. Perform complete and accurate documentation of inspection activities,...

  • Sr Associate, Customer Success

    2 months ago

    Akron, United States DRB Systems LLC Full time

    Job DescriptionJob DescriptionDRB (A Vontier Company) is the leading provider of technology-enabled devices and software solutions to the North American car care industry.WHAT WE DO: enabling the future of vehicle care – wherever the road takes you.WHY WE DO IT: To fuel our client’s growth with connected, data-led technology, driven by our spirit of...

  • Manager, Quality Assurance

    6 days ago

    Akron, United States Structural Integrity Associates, Inc. Full time

    Job DescriptionJob DescriptionStructural Integrity Associates, Inc. (SIA) is looking for a motivated and experienced Quality Assurance Manager to join our company. The purpose of this role is to provide a full range of quality activities in direct support of the company’s business and support teams across the enterprise including responsibility for a...

  • Quality Assurance Specialist

    1 week ago

    Akron, Ohio, United States OGS Industries Full time

    Job OverviewSalary: OGS Industries is a family-owned enterprise specializing in stamping, fabrication, and machining services across various sectors including aerospace, transportation, railroad, general industrial, and military markets. With three facilities and a dedicated team of over 120 employees, we pride ourselves on offering exceptional medical...

  • Quality Control Technician

    2 days ago

    Akron, Ohio, United States S&A Industries Corporation Full time

    Job Summary:S&A Industries Corporation is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Communicate quality concerns with urgency and accuracy.Perform thorough and accurate documentation of...

  • Quality Assurance Analyst

    1 week ago

    Akron, Ohio, United States TBA Full time

    Position Overview:The Quality Assurance Specialist is integral to the cGMP quality operations within Vector External Manufacturing. Key responsibilities encompass the evaluation of cGMP Controlled Documents, including Standard Operating Procedures (SOPs), specifications, completed batch records, and material disposition. This role is essential in managing...

  • Quality Assurance Analyst

    1 week ago

    Akron, Ohio, United States TBA Full time

    Position Overview:The Quality Assurance Specialist is integral to the support of cGMP quality operations within Vector External Manufacturing. Key responsibilities encompass the examination of cGMP Controlled Documents, including Standard Operating Procedures (SOPs), specifications, completed batch records, and material disposition, while managing the...

  • Quality Assurance Specialist

    1 month ago

    Akron, United States KRA Corporation Full time

    Job DescriptionJob DescriptionIn addition to a competitive compensation, this position is also eligible for a sign-on bonus!KRA is seeking a dynamic Quality Assurance Specialist to develop monitoring procedures, performs quality assurance and customer satisfaction assessments, develops and analyzes reports and makes recommendations for program improvement....

  • Hydraulic Systems Engineer

    1 week ago

    Akron, Ohio, United States ARCADIS Full time

    Company Overview:Arcadis stands as a global leader in providing sustainable design, engineering, and consultancy services for both natural and constructed assets. With a dedicated workforce of over 36,000 professionals across more than 70 countries, we are committed to enhancing the quality of life for communities worldwide.Our mission is driven by a...

  • Quality Inspector

    3 weeks ago

    Akron, United States OGS Industries Full time

    OGS Industries provides stamping, fabrication, and machining services to the aerospace, transportation, railroad, general industrial, and military markets. We are a family-owned business with 3 facilities and over 120 employees. We provide superior medical benefits, flexible hours as needed, and a fun/positive work environment. We are growing and seeking to...

  • Quality Assurance Analyst

    1 week ago

    Akron, Ohio, United States TBA Full time

    Position Overview:The Quality Assurance Specialist is integral to ensuring the compliance of cGMP quality operations within Vector External Manufacturing. Key responsibilities encompass the evaluation of cGMP Controlled Documents, including Standard Operating Procedures (SOPs), specifications, completed batch records, and material disposition. This role is...

  • Quality Inspector

    4 weeks ago

    Akron, United States OGS Industries Full time

    OGS Industries provides stamping, fabrication, and machining services to the aerospace, transportation, railroad, general industrial, and military markets. We are a family-owned business with 3 facilities and over 120 employees. We provide superior medical benefits, flexible hours as needed, and a fun/positive work environment. We are growing and seeking to...

  • Quality Inspector

    1 month ago

    Akron, United States OGS Industries Full time

    Job DescriptionJob DescriptionSalary: OGS Industries provides stamping, fabrication, and machining services to the aerospace, transportation, railroad, general industrial, and military markets. We are a family-owned business with 3 facilities and over 120 employees. We provide superior medical benefits, flexible hours as needed, and a fun/positive work...

  • Research Scientist

    4 days ago

    Akron, Ohio, United States Cynet Systems Full time

    Job OverviewWe are seeking a Research Scientist for our client.Position Title: Research ScientistLocation: Summit, NJEmployment Type: ContractCompensation: $46/hr - $49/hrKey Responsibilities:Conduct comprehensive investigations including Environmental Monitoring and deviations, utilizing root cause analysis methodologies.Lead investigations and...