Quality Systems Associate

Grifols; Pueblo (CO); On-site; USD 27,000 - 36,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Paid Time Off

401(k) Match

Tuition Reimbursement

Job summary

Grifols is seeking a Quality Systems Associate in Pueblo, CO to support quality assurance and training under the Quality Systems Manager. The role focuses on ensuring compliance with cGMP, SOPs, and regulatory requirements and includes reviewing records, investigating deviations, and assisting with product release activities.

You will help maintain training records, observe staff competency, and participate in center audits.

Qualifications

• High school diploma or GED.
• No prior related experience required.
• Knowledge of FDA regulations and cGMP.
• Ability to work in a plasma center environment and handle documentation.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints related to quality and donor safety.
• Inspects and releases incoming supplies; investigates unmet quality specifications.
• Performs documentation review for unsuitable test results.
• Assists with product release activities and regulatory compliance.
• Reviews donor center records and training materials.

Skills

Quality assurance

Training

Root-cause analysis

Documentation review

cGMP knowledge

FDA regulations

Donor safety

SOP compliance

Problem solving

Attention to detail

Education

High school diploma or GED

Job description

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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.

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The estimated pay scale for the Quality Systems Associate role based in Pueblo, CO , is $19.38-26.22per hour. Additionally, the position is eligible to participate in up to 5 % of thecompanybonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision,life insurance,PTO,paid holidays andup to 5% 401(K) match and tuition reimbursement. Final compensation packages willultimately dependon education, experience, skillset, knowledge, where the role is performed, internalequityand market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

APPLICATION DEADLINE DATE = 11/09/26 @ 11:59PM LOCAL TIME.

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.