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Quality Systems Associate
GrifolsQuality Systems Associate responsible for quality assurance and training at a plasma center. Ensuring compliance with internal and external regulations related to product quality and safety protocols.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates a strong understanding of FDA regulations and cGMP compliance while performing quality assurance and training functions. Capable of conducting root-cause analysis and maintaining accurate documentation to ensure adherence to quality systems.
Highest-signal resume keywords
FDA Regulations UnderstandingCGMP ComplianceQuality AssuranceRoot-Cause AnalysisTraining and Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality ControlDocumentation ReviewMathematics ProficiencyRoot-Cause AnalysisTraining Record Maintenance
Soft Skills
Interpersonal CommunicationOrganizational SkillsProblem-Solving SkillsIntegrityCommitment to Quality
Tools & Technologies
Computer Proficiency
Industry Keywords
CGMPQuality SystemsSOPsRegulatory RequirementsDonor Center Compliance
About the role
Key responsibilities & impact- Perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol
- Completes weekly review of equipment QC and maintenance records
- Documents, investigates, and performs root-cause analysis for deviations and customer complaints
- Inspects and releases incoming supplies
- Performs documentation review for unsuitable test results
- Assists the Quality Systems Manager to ensure cGMP regulation, SOPs and regulatory requirements are followed
- Creates, maintains, and audits training records and files to ensure compliance
- Conduct employee training observations
- Reviews lookback information and documentation
- Conducts training to address donor center corrective and preventive measures
Requirements
What you’ll need- High school diploma or GED
- Ability to understand FDA regulations
- Basic understanding of cGMP and quality systems
- Developing command of interpersonal communication, organizational and problem-solving skills
- 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
Benefits
Comp & perks- Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear.