Quality Systems Associate

Grifols, S.A; Los Angeles (CA); On-site; USD 50,918 - 68,890; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

PTO

Paid holidays

401(k) match

Tuition reimbursement

Job summary

Grifols, S.A. in Los Angeles seeks a Quality Systems Associate to support quality assurance and training, ensuring compliance with FDA regulations and cGMP under the Quality Systems Manager. You will document deviations, perform investigations, and manage training records.

The role covers weekly QC reviews, release of supplies, product release activities, and center audits. No prior experience required; strong attention to detail and organizational skills are essential.

Qualifications

• High school diploma or GED.
• Typically requires no previous related experience.
• Exposure to plasma center environment and handling of documentation.

Responsibilities

• Review weekly equipment QC and maintenance records.
• Investigate deviations and customer complaints related to product quality.
• Inspect and release incoming supplies and report nonconforming items.
• Review documentation for test results and ensure regulatory compliance.
• Assist with cGMP requirements and SOP adherence.
• Perform product release activities and training records audits.
• Review donor-related documentation and center audits.

Skills

Interpersonal skills

FDA regulations

Quality compliance

Math skills

Legible handwriting

Flexible scheduling

Documentation review

SOP adherence

cGMP knowledge

Attention to detail

Education

High school diploma or GED

Job description

Quality Systems Associate

Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols.

Primary Responsibilities:

• Complete weekly review of equipment QC and maintenance records.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints related to product quality and donor safety.
• Inspect and release incoming supplies; investigate and report supplies that have not met quality specifications before use.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure cGMP regulations, SOPs, and regulatory requirements are followed.
• Perform all product release activities.
• Review lookback information and documentation.
• Review waste shipment documentation.
• Review unexpected plasmapheresis events and related electronic donor chart documentation.
• Review electronic donor chart exceptions affecting donor eligibility, safety, and product quality.
• Review donor deferral notifications from competitor centers.
• Review plasma processing documentation to ensure proper freezing, storage, and handling of product.
• Create, maintain, and audit training records and files to ensure compliance.
• Perform employee training observations to ensure staff competence before independent work.
• Conduct required training activities for center notifications, corporate directives, SOP changes, and initial SOP implementations.
• When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with the completion of internal donor center audits.

Additional Responsibilities:

• Maintain certification as a Donor Center Technician.

Knowledge, Skills, and Abilities:

• Strong interpersonal communication, organizational, and problem‑solving skills.
• Understanding of FDA regulations.
• Integrity and commitment to quality and compliance.
• Proficiency with mathematics and computers.
• Legible handwriting.
• Ability to work flexible scheduling to meet business needs.
• Basic document review and employee observation skills.
• Open communication with the CQM on issues noted during reviews.
• Following SOPs and protocols.
• Ability to perform primary responsibilities proficiently.
• Basic understanding of cGMP and quality systems.
• Ability to spend hours reviewing documentation for accuracy.
• Strong 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 and potential infectious organisms; exposure to electrical office and laboratory equipment; exposure to extreme cold below 32°F during reviews in plasma freezers. Personal protective equipment required including protective eyewear, garments, gloves, and cold‑gear. Work is performed mostly while sitting for up to 4–6 hours per day and standing 2–4 hours per day. The position requires bending, twisting, and frequent hand, wrist, and foot movements, occasional lifting of up to 15 lbs and a maximum lift of 50 lbs, and some light walking and squatting. Hearing quality required; color perception and vision corrections specified for one eye. Ability to communicate information effectively to diverse groups and to work independently with minimal guidance.

Benefits:

This role’s estimated pay range is $24.48–$33.12 per hour, with eligibility for up to 5% of the company bonus pool. Benefits include medical, dental, vision, life insurance, PTO, paid holidays, up to 5% 401(K) match, and tuition reimbursement.

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.