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Senior Specialist, External Quality
Johnson & Johnson. Provide quality assurance support and oversight for external Synthetic manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality assurance and compliance within GMP-regulated environments, focusing on external manufacturing operations, risk management, and continuous improvement. Proficient in quality metrics, CAPA processes, and effective communication with internal and external stakeholders.
Highest-signal resume keywords
Quality AssuranceGMP ComplianceCAPA ProcessesRisk ManagementQuality Metrics
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 ManagementQuality ControlRoot Cause AnalysisDeviation ManagementChange ControlBatch ReleaseQuality Agreement ReviewTechnical DocumentationProduct Lifecycle ManagementProcess Improvement
Soft Skills
Excellent CommunicationCollaborationIndependent WorkTime ManagementProfessionalism
Tools & Technologies
Microsoft OfficeQuality System Tools
Industry Keywords
PharmaceuticalBiotechnologyCGMPICH RequirementsExternal ManufacturingContract Manufacturing OrganizationsHealth Authority InspectionsProduct TransferNew Product IntroductionParenteral Products
About the role
Key responsibilities & impact- Provide quality assurance support and oversight for external Synthetic manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities
- Review, coordinate and provide quality concurrence or approval for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements
- Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends
- Identify, communicate and escalate quality, compliance or supply risks and support risk-based mitigation and remediation plans
- Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners
- Collaborate with External Quality Site Leads, Product Quality, MSAT, Planning, Procurement, Regulatory, EHS, Qualified Persons and external partners
- Support external manufacturers during J&J audits, health authority inspections and regulatory commitments
- Participate in technology transfer, new product introduction, product lifecycle management, process improvement and risk management initiatives
- Contribute to continuous improvement of External Quality processes, documentation practices, quality culture and performance management
Requirements
What you’ll need- Minimum of a Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline
- Minimum of 4 years of experience in quality management, quality assurance, production, quality control, R&D or a related pharmaceutical and/or biotechnology environment
- Experience working in a GMP-regulated environment, preferably including quality support for external manufacturing, drug product or drug substance manufacturing, packaging, testing, release or commercial supply
- Working knowledge of cGMP, ICH requirements, quality systems and applicable health authority expectations
- Ability to review and assess quality records, identify gaps, support root cause analysis and contribute to effective CAPA and risk-based decision-making
- Excellent verbal and written communication skills, including the ability to communicate effectively with internal functions and external partners
- Ability to work independently with minimal supervision, manage multiple priorities, meet tight timelines and maintain a collaborative and professional approach
- Excellent computer proficiency, including Microsoft Office and standard quality system tools
- Experience with deviation, CAPA, change control, complaint, batch release, quality agreement, audit or inspection support processes
- Preferred: Experience working with external manufacturers, contract manufacturing organizations, external contract laboratories or strategic partners
- Preferred: Experience working on cross-functional project teams
- Preferred: Experience with product transfer, new product introduction, parenteral, and/or combination products
Benefits
Comp & perks- Inclusive work environment
- Up to 25% domestic and international travel may be required