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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance processes, including compliance with cGMP and effective communication across organizational levels. Proficient in quality systems management and problem-solving within defined operational frameworks.
Highest-signal resume keywords
QA Work ExperienceExperience Reviewing BPRsBS/BA Degree in STEMKnowledge of cGMPFamiliarity with Quality Systems
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Batch ReleaseData AnalysisProblem ResolutionQuality Input for ValidationDocumentation Management
Soft Skills
Excellent Organizational SkillsEffective Communication SkillsDetail-OrientedEfficient Work Style
Tools & Technologies
SAPSAP Quality ModuleChange ControlDiscrepancy ManagementQuarantine
Industry Keywords
Quality AssuranceComplianceCGMPProduct ReleaseTraining
About the role
Key responsibilities & impact- Provide routine technical support for documentation, training, compliance, product release, scheduling, assignments, and projects
- Perform final container product release
- Perform batch-related activities and meet cycle-time release targets
- Collect, review, and potentially analyze data
- Make decisions within defined areas and resolve problems according to SOPs and established practices
- Supervise or train employees as needed
- Communicate effectively across all organizational levels
- Participate as author, reviewer, administrator, or coordinator in quality systems
- Provide Quality input for validation, capital engineering, clinical, stability, ETP, and regulatory projects or submissions
- For QA III, develop alternative solutions to complex problems and represent Quality at business-unit and project meetings
Requirements
What you’ll need- QA work experience
- Experience reviewing BPRs
- Excellent organizational skills
- Communication skills
- Detail-oriented
- Efficient work style
- QA II: BS/BA degree preferably in STEM and minimum 2 years of related experience, or equivalent combination of education and experience
- QA III: BS/BA degree preferably in STEM and minimum 3 years of relevant experience, or equivalent combination of education and experience
- Ability to follow cGMP and department safety practices
- Ability to work with quality systems including Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, and Documentation
Benefits
Comp & perks- Equal employment opportunities without regard to protected characteristics
- Day shift schedule
