--- title: Quality Assurance Engineer at Contract Pharmacal description: Contract Pharmacal is hiring for the Quality Assurance Engineer role in Hauppauge, NY. Full-time role. See the full description and apply. type: job url: https://www.foundrole.com/jobs/quality-assurance-engineer-at-contract-pharmacal-corp-01a0e011-7237-724d-96ca-a3a85561db44 date: 2026-09-28T20:57:33Z og_description: Join Contract Pharmacal as Quality Assurance Engineer in Hauppauge, NY. Pays $80K–$110K per year. Full-time role. og_image: https://www.foundrole.com/og/yzd3to.png breadcrumbs: - label: Home url: https://www.foundrole.com/ - label: Search url: https://www.foundrole.com/jobs --- | | | |---|---| | **Company** | Contract Pharmacal | | **Location** | Hauppauge, NY | | **Salary** | $80K/yr - $110K/yr | | **Type** | Full Time | | **Posted** | Sep 26, 2026 | ## Description 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. Job Type: Full-Time Location: Hauppauge, NY Work Hours: Monday-Friday 8:00AM-4:00PM Pay Range: $80,000 - $110,000 per year, depending on experience Start Date: ASAP **Why Join CPC?** At CPC, you’ll be part of a team that has set the standard in pharmaceutical development and contract manufacturing since 1971, helping bring high-quality OTC, dietary supplement, and prescription products to market faster and safer than ever. We pride ourselves on quality as a core value, innovative problem-solving, and a collaborative culture where everyone plays a role in advancing formulation and manufacturing excellence. CPC offers an inclusive, respectful workplace with opportunities to grow your skills and career while working with cutting-edge technologies and serving leading global brands. With a commitment to employee success, competitive benefits, and a culture built on teamwork and integrity, CPC is a place where your contributions truly make an impact. **·** 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. **Education & Experience:** **·** 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. **Skills and Abilities:** **·** 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. ## Skills - Enterprise Resource Planning - Project Management - Quality Management System (Qms) - Decision Making - Influencing Skills - Inspection - Data Visualization - Perspective (Graphical) - Investigation - Microsoft Excel - Critical Thinking - Quality Engineering - Root Cause Analysis - Technical Writing - Minitab - Microsoft Word - Statistics - Microsoft Outlook - USP Standards Compliance - Six Sigma - Microsoft Office - Corrective And Preventive Action (Capa) - Written Communication - ICH GCP Guidelines - Microsoft PowerPoint - FDA Regulations - Data Analysis - Quality Assurance - Pivot Tables And Charts - Communication - Writing - Databases ## How to Apply [Apply for this position](https://www.foundrole.com/jobs/quality-assurance-engineer-at-contract-pharmacal-corp-01a0e011-7237-724d-96ca-a3a85561db44?utm_source=ai_markdown) ## Related - [Browse all companies](https://www.foundrole.com/companies?utm_source=ai_markdown)