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Senior Quality Associate I, QA, Final Container Release
GrifolsSenior Quality Associate I at Grifols ensuring quality compliance in healthcare products. Involves management consultation, data analysis, and technical solution implementation with cross-functional teams.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality management and regulatory compliance, with a strong focus on cGMP practices and data analysis. Proficient in preparing technical documentation and advancing project proposals within a multi-disciplinary team environment.
Highest-signal resume keywords
Quality ManagementData AnalysisCGMP ComplianceSAP QMRegulatory Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data CollectionTechnical Report PreparationSOP RevisionProject Proposal DevelopmentQuality Decision Making
Soft Skills
Independent Decision MakingCollaborationGuidance Following
Tools & Technologies
SAP QM
Industry Keywords
FDA RegulationsRegulatory Agency GuidelinesMarket RequirementsTechnical Resources Deployment
About the role
Key responsibilities & impact- Consults with management to develop and implement solutions for achieving quality related objectives
- Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals
- Uses expertise to make independent decisions within defined areas of responsibility
- Participates on multi-disciplined project teams
- Advances technical project proposals to senior management
- Collects and analyzes data
- Prepares and reviews SOP revisions, technical reports in DCM, and Change Control Requests
- Demonstrates ability to make sound quality decisions with moderate guidance
- Follows cGMP and department safety practices
Requirements
What you’ll need- BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline
- Minimum of 5 years relevant experience, or equivalent combination of education and experience
- Basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines
- Knowledge of current products, product specifications, different market requirements and regulations is preferred
- Knowledge of SAP QM is highly preferred.
Benefits
Comp & perks- Health insurance
- 401(k) plan
- Paid time off
- Professional development opportunities
- Flexible work arrangements