Quality Systems Engineer

CONTRACT PHARMACAL CORP•Town of Smithtown, NY

just now•$80,000 - $110,000•Onsite

About The Position

The Quality Systems Engineer is a key member of the Quality Assurance unit, responsible for leading and enhancing quality system activities including but not limited to quality event investigations (deviations, complaints, con-conformances and OOS) protocol writing (reworks and reprocessing) risk assessments and CAPAs. The Quality Systems Engineer applies engineering, analytical, and risk-based thinking to identify systemic issues, improve process robustness, and strengthen inspection readiness.

Requirements

Bachelor’s degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical discipline (advanced degree a plus).
5 or more years of experience in Quality Assurance or Quality Engineering within a pharmaceutical, biotech, or regulated manufacturing environment preferred.
Certifications for Six Sigma, Root Cause Analysis, Project Management, Technical Writing, cGMP, advanced data analysis preferred.
Demonstrated experience leading quality event investigations, protocol writing, risk assessments and CAPAs.
Exceptional technical writing skills with the ability to produce clear, concise, and inspection-ready documentation.
Strong working knowledge of cGMPs, FDA regulations, ICH/USP/EP guidelines, and quality systems.
Advanced root cause analysis and critical thinking
Proficient in data analysis, data visualization, and data analytics tools such as Minitab and Excel (including PivotTables, VLOOKUP, INDEX/MATCH, SUMPRODUCT, etc.).
Ability to fluently interface with electronic systems and databases such as ERP, QMS, Stability etc.
Strong systems-level perspective (ability to see patterns beyond individual events)
Risk-based decision-making
Ability to influence without authority
Comfort challenging assumptions and elevating quality discussions
Data-driven mindset with the ability to translate trends into action
Excellent verbal and written communication skills
Proficiency in Microsoft Office Suite including Word, Excel, Outlook, and PowerPoint.

Responsibilities

Lead and author complex quality event investigations (deviations, complaints, non-conformances, and OOS), protocols (reworks and reprocessing), risk assessments and CAPAs.
Apply structured problem-solving methodologies (e.g., lean and six-sigma, DMAIC, root cause analysis, FMEA, fishbone, 5-Why) to drive high-quality, defensible conclusions.
Ensure all documentation meets cGMP, FDA, EMA, and internal quality standards, with a focus on clarity, logic, and inspection-ready narratives.
Review and challenge investigation content prepared by cross-functional teams to elevate overall quality and consistency.
Drive the development of robust, risk-based CAPAs that address true root causes rather than symptoms.
Assess CAPA effectiveness and sustainability; identify trends and opportunities for system-level improvements.
Partner with functional owners to ensure timely implementation and closure of quality actions.
Analyze trends across quality vents to identify systemic risks, recurring failure modes, and opportunities for process improvement.
Support continuous improvement initiatives by translating quality data into actionable insights.
Contribute to the design or enhancement of quality processes, templates, and tools to improve investigation quality and efficiency.
Serve as a thought partner to operations and technical teams during issue resolution and change management activities.
Act as a trusted QA partner to Manufacturing, Packaging, Engineering, Technical Operations, Accounts Management, and Supply Chain.
Provide risk-based quality input to support sound business decisions while maintaining regulatory compliance.
Support inspection readiness activities, including responses to regulatory questions related to investigations and CAPAs.
Complete internal audits and support external audits of CPC operations.
Mentor junior QA staff or investigators by modeling high-quality investigation practices.
Other responsibilities as assigned by Senior Management.