Quality Systems Associate

Grifols; Los Angeles (CA); On-site; USD 33,062 - 45,460; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401(k) match

Tuition reimbursement

Paid time off

Job summary

Grifols in Van Nuys, CA is seeking a Quality Systems Associate to perform quality assurance and training functions ensuring regulatory and protocol compliance under the supervision of the Quality Systems Manager.

Responsibilities include reviewing equipment QC, investigating deviations, inspecting supplies, and maintaining training records while upholding cGMP standards and company policies across the donor center operations.

Qualifications

• High school diploma or GED.
• State licensures or certifications may apply.
• Typically no previous related experience required.

Responsibilities

• Complete weekly review of equipment QC and maintenance records.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints, specifically related to product quality and/or donor safety.
• Inspect and release incoming supplies; investigate and report supplies that have not met quality specifications and requirements prior to use.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
• Perform all product release activities.
• Review lookback information and documentation.
• Review waste shipment documentation.
• Review unexpected plasmapheresis events including electronic donor chart and related documentation of exceptions during the donation process.
• Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
• Review donor deferral notifications from competitor centers.
• Review plasma processing documentation to ensure proper freezing, storage and handling of product.

Skills

Interpersonal communication

FDA regulations

Quality assurance

Attention to detail

Legible handwriting

Computer proficiency

SOP adherence

Document review

Organizational skills

Problem solving

Education

High school diploma or GED

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

• Complete weekly review of equipment QC and maintenance records.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints, specifically related to product quality and/or donor safety.
• Inspect and release incoming supplies; investigate and report supplies that have not met quality specifications and requirements prior to use.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
• Perform all product release activities.
• Review lookback information and documentation.
• Review waste shipment documentation.
• Review unexpected plasmapheresis events including electronic donor chart and related documentation of exceptions during the donation process.
• Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
• Review donor deferral notifications from competitor centers.
• Review plasma processing documentation to ensure proper freezing, storage and handling of product.

Training and Auditing Responsibilities

• 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.
• Create, maintain, and audit training records and files to ensure compliance.
• Perform employee training observations to ensure staff competency prior to releasing employees to work independently.
• Conduct required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
• When the Quality Systems Manager is absent, the Quality Systems Associate may be required to:
  • Review and approve deferred donor reinstatement activities.
  • Assist with completion of the internal donor center audit.

Additional Activities

• Review monthly trending reports.
• Review donor adverse events reports and the applicable related documentation.
• Conduct training to address donor center corrective and preventative measures.
• Maintain 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.
• Perform basic document review and employee observations.
• Communicate openly with the CQM on issues noted during reviews.
• Understand and follow SOPs and protocols.
• Perform primary responsibilities of the Quality Associate role in a proficient manner.
• Basic understanding of cGMP and quality systems.
• Spend hours sitting and reviewing documentation for accuracy.
• Demonstrate good organizational skills and attention to detail.

Education

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

Experience

Typically requires no previous related experience.

Occupational Demands

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 involves bending and twisting of neck 2 to 4 hours per day. Frequent hand movement with the ability to make fast, simple movements of the fingers, hands, and wrists. Able 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 occasions. Occasionally walks, bends and twists at waist. Light lifting of 15 lbs. with a maximum lift of 50 lbs. 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. Communicate information and ideas so others will understand; listen to and understand information and ideas presented through spoken words and sentences. Work independently with little guidance or reliance on oral or written instructions. Perform a wide range of tasks as dictated by variable demands and changing conditions. Relate sensitive information to diverse groups.

Compensation and Benefits

The estimated pay scale for the Quality Systems Associate role based in Van Nuys, CA, is $24.48‑33.12 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(k) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and 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!

Location

North America: USA: CA‑Van Nuys: USVAN – Van Nuys CA‑Vanowen St-BIO

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.