Quality Systems Associate

Grifols SA•Chicago, IL

41d•$23 - $32•Onsite

About The Position

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 Pay scale of $23.46-31.74/ per hour. This position is eligible to participate in up to 4% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us! 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.

Requirements

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.
High school diploma or GED.
Obtains state licensures or certifications if applicable.
Typically requires no previous related experience.

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.
Assists with completion of the internal donor center audit.
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.