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Quality Systems Associate
GrifolsQuality Systems Associate under Quality Systems Manager ensuring compliance with health regulations. Handling quality assurance activities and training within a plasma center environment.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates a solid understanding of cGMP and FDA regulations while ensuring compliance and quality assurance in all processes. Capable of performing root-cause analysis and maintaining accurate documentation to support quality systems.
Highest-signal resume keywords
Understanding Of cGMPKnowledge Of FDA RegulationsRoot-Cause AnalysisDocumentation ReviewTraining Record Maintenance
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 AssuranceMathematics ProficiencyDocumentation SkillsEquipment QC ReviewSOP Understanding
Soft Skills
IntegrityCommitment To QualityFlexibility
Tools & Technologies
Computer Proficiency
Certifications & Qualifications
High School DiplomaGED
Industry Keywords
Quality SystemsRegulatory RequirementsCustomer ComplaintsIncoming Supplies Inspection
About the role
Key responsibilities & impact- Perform quality assurance and training functions under the supervision of the Quality Systems Manager
- 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 regulatory requirements are followed
- Creates, maintains, and audits training records and files
Requirements
What you’ll need- High school diploma or GED
- No previous related experience required
- Basic understanding of cGMP and quality systems
- Ability to understand FDA regulations
- Proficiency with computers
- Strong integrity and commitment to quality and compliance
- Good knowledge of mathematics
- Legible handwriting
- Ability to work flexible scheduling to meet business needs
- Ability to understand and follow SOP’s and protocols
Benefits
Comp & perks- Regular Full-Time position
- International team working to improve the future of healthcare
- Competitive compensation
- Certification opportunities