FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality control and regulatory compliance within a medical and cGMP regulated environment, with a strong focus on process improvement, root cause analysis, and effective training management. Proficient in interpreting and implementing SOPs, FDA regulations, and quality standards to ensure donor safety and product quality.
Highest-signal resume keywords
Quality ControlRegulatory ComplianceRoot Cause AnalysisCGMP StandardsQuality Systems Management
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 InspectionCorrective ActionsProcess ImprovementTrend AnalysisDocumentation ReviewSOP ImplementationFDA RegulationsQuality Analysis ReportingTraining ManagementBiohazard Waste Management
Soft Skills
CollaborationCommunicationProblem-SolvingCustomer SatisfactionTeam Leadership
Certifications & Qualifications
Bachelor of Science DegreeCertified Quality AuditorDesignated Trainer Certification
Industry Keywords
CGMPMedical EnvironmentPlasmaWhole BloodQuality StandardsDonor SafetyCompliance StatusInternal AuditsExternal AuditsPersonal Protective Equipment
About the role
Key responsibilities & impact- Evaluate processes, develop action plans, and coordinate strategic implementation of system processes and corrective actions
- Perform independent quality inspection and control to ensure center compliance with quality standards and regulations
- Collaborate with Center Managers to ensure product quality, donor suitability, and donor safety
- Direct and monitor processes for compliance with state, federal, and company regulations
- Ensure Standard Operating Procedures are interpreted and implemented properly
- Interpret and implement processes, regulations, and SOPs for quality control and regulatory compliance
- Oversee internal and external audits, including documentation, responses, and corrective/preventive actions
- Assess and improve quality-system effectiveness through trend recognition, failure investigations, employee observation, and document review
- Manage Quality Systems Associate personnel functions, including work assignment, hiring, training, scheduling, performance actions, and records
- Oversee product and biohazard waste shipments, including labeling, documentation, and final shipment authorization
- Review unsuitable test results and associated dispositions
- Document, investigate, and perform root-cause analysis for deviations and customer complaints
- Track and trend quality incidents and report critical incidents and problematic trends
- Report compliance status to relevant parties
- Ensure donor-file accuracy and appropriate supply storage and quality compliance
- Direct equipment maintenance, calibration, and procedure documentation
- Ensure CLIA proficiency tests, complaint investigations, and training are documented
- Monitor training documentation and cGMP training completion
- Track corrective/preventive actions, system implementations, and process-improvement plans
- Ensure required QC checks are performed and acceptable
- Verify SOPs and forms are current
- Partner with the Center Manager on donor suitability and donor deferrals
- Prepare quality-analysis reports and research systemic compliance issues
- Build rapport with donors to support customer satisfaction and long-term donation
- Review deferred-donor reinstatements, lookback information, and medical incident reports
- Lead regional and divisional projects and initiatives
Requirements
What you’ll need- Bachelor of Science degree or equivalent
- Certified and proficient in quality and compliance
- Works toward certification from American Society for Quality to be a Certified Quality Auditor
- Works toward certification as a Designated Trainer for quality area is required
- Typically requires 2-5 years of related work experience in a medical and/or cGMP regulated environment
- Experience with plasma or whole blood
- Ability to understand and assess FDA regulations
- Proficiency in root cause analysis and corrective/preventative actions
- High level of proficiency with computers
- Ability to travel when needed for meetings, events, and occasional support of other centers
- Ability to work with minimal supervision
- Ability to maintain quality and compliance standards
- Directly related work experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements
- Exposure to biological fluids, infectious organisms, electrical office equipment, extreme cold, chemicals, moving machinery, production equipment, and high noise levels
- Ability to use required personal protective equipment
- Ability to lift and carry up to 35 pounds
- Ability to travel within the United States
Benefits
Comp & perks- Up to 20% of the company bonus pool
- Medical
- Dental
- Vision
- PTO
- Paid holidays
- Tuition reimbursement
- Up to 5% 401(K) match
- Opportunities for professional growth and career progression
