Implements tactical and operational quality assurance goals, focusing on ensuring compliance with quality standards and continuous improvement initiatives.
Contributes to implementing new testing protocols, inspection processes, regulatory compliance measures, or operational quality assurance plans, such as refining defect detection methods, enhancing validation procedures, and optimizing corrective action workflows.
Manages quality assurance projects and/or processes, such as overseeing supplier audits, coordinating process validation initiatives, and supporting product quality enhancements through statistical analysis and testing optimization.
Works on problems and issues with a diverse scope where analysis of information requires evaluation of multiple factors, such as balancing production efficiency with defect reduction, troubleshooting inconsistencies in testing data, and adapting quality control measures to meet evolving industry standards.
Derives solutions based on limited information and/or precedents, such as developing proactive defect prevention strategies, refining standard operating procedures to address recurring compliance challenges, and implementing root cause analysis methodologies to resolve complex manufacturing quality issues.
Communicates with parties within and outside of the quality assurance function, including customers, vendors, and regulatory bodies, ensuring alignment on quality standards, addressing compliance concerns, and supporting the resolution of product-related inquiries.
Skills/Experience:
Quality Engineer leads efforts in site quality assurance programs and improvement activities. He/she is responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements. The Senior Quality Engineer is accountable for direct support of several systems, including CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC (supporting the microelectronic, pharmaceutical and reagent product lines as necessary) and Validation. Quality Engineer acts as the key contact working directly with customers to investigate and resolve complaints and inquiries to ensure expectations are met as well as hosting and managing customer audits, certification/surveillance audits as well as the internal audit program. He/she works collaboratively with other departments in both a leadership and participative manner to integrate the necessary systems. Work Schedule:1st Shift (Monday - Friday)
Required Skills:
QUALIFICATIONS:
Minimum of five (5) years of experience in quality engineering or a related role required
Experience working within pharmaceutical, biotechnology and/or chemical environments required
Experience working within cGMP/ISO 9000 regulated environments required
Numbers & Facts
Location
Phillipsburg, NJ
Skills
Analysis Skillsunmatched
Auditingunmatched
Biotech and Pharmaceuticalunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Environmental Chemistryunmatched
FDA Requirementsunmatched
ISO (International Organization for Standardization)unmatched
ISO 9000unmatched
Industry Standardsunmatched
Internal Auditunmatched
Leadershipunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Operational Measurementunmatched
Operations Planningunmatched
Problem Solving Skillsunmatched
Process Managementunmatched
Process Validationunmatched
Product Supportunmatched
Quality Assuranceunmatched
Quality Assurance Methodologyunmatched
Quality Controlunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality Metricsunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Resolve Customer Issuesunmatched
Root Cause Analysisunmatched
Standard Operating Procedures (SOP)unmatched
Standards Strategyunmatched
Statisticsunmatched
Surveillanceunmatched
System Integration (SI)unmatched
Tactical Operationsunmatched
Test Dataunmatched
Testingunmatched
Vendor/Supplier Evaluationunmatched
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