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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality management, including monitoring product quality, resolving non-conformances, and adhering to GxP regulations and SOPs. Proven ability to lead teams, analyze audit trends, and collaborate effectively with cross-functional personnel to enhance product quality.
Highest-signal resume keywords
Quality ManagementGxP RegulationsNon-Conformance ProcessAudit Trends AnalysisCollaboration with Cross-Functional Teams
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 ManagementProblem SolvingProduct Quarantine ActivitiesNon-Conformance ReportingScientific Principles ApplicationEngineering Principles ApplicationProcess ImprovementTrend AnalysisTraining Requirements Compliance
Soft Skills
Decision MakingCommunicationLeadershipCollaborationAttention to Detail
Industry Keywords
FDA RequirementsISO StandardsSOPsQuality EngineeringManufacturing ProcessesOperations ComplianceQuality AssuranceAdvanced Quality ManagementProduct QualityDocumentation Standards
About the role
Key responsibilities & impact- Handle complex tasks and contribute to advanced quality management projects
- Make significant decisions within the project area
- Monitor product quality and resolve non-conformances
- Maintain documentation and records
- Apply scientific and engineering principles to solve problems and innovate
- Lead the Quality function in the Production Triage team
- Direct and support the non-conformance process and product quarantine activities
- Initiate nonconformance reports and identify and implement applicable activities
- Perform product quarantine activities, including documentation, review, disposition, release, and removal of product
- Stay current with advances in the field and refine solutions through testing and iteration
- Follow GxP regulations, SOPs, quality controls, documentation, and training requirements
- Audit manufacturing personnel and processes against procedures and FDA/ISO requirements
- Analyze audit trends and provide feedback to QA Operations management and the QA team
- Collaborate with Operations, Quality Engineering, Compliance, and Engineering personnel
- Participate in work groups to improve processes and product quality
Requirements
What you’ll need- High School Diploma or Equivalent; bachelor’s degree preferred
- Ability to fluently read, write, understand and communicate in English
- 3 Years of Relevant Experience
- Must work onsite in Johns Creek, Georgia
- Availability for 1st Shift, Monday–Friday, 8:00AM–5:00PM EST
- Must follow GxP regulations and Standard Operating Procedures (SOPs)
- Must complete required training
- Sponsorship and relocation are not available
Benefits
Comp & perks- Health benefits
- Life insurance
- Retirement benefits
- Flexible time off for exempt associates
- PTO for hourly associates
- Focused growth and development opportunities
- Inclusive work environment
- Reasonable accommodation for individuals with disabilities