Contract Pharmacal Corp · 6 hours ago
Quality Systems Engineer
Hauppauge,NY,US
Full-time
Onsite
Mid, Senior Level
$80K/yr - $110K/yr
5+ years expContract Pharmacal Corp is a leader in pharmaceutical development and contract manufacturing. The Quality Systems Engineer will lead and enhance quality system activities, focusing on quality event investigations, protocol writing, and CAPAs to improve process robustness and ensure inspection readiness.
BiotechnologyPharmaceutical
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
Qualification
Required
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
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
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
Preferred
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
Company
Contract Pharmacal Corp
Contract Pharmacal Corp is a pharmaceuticals company specializing in solid dose drugs and dietary supplements.
1001-5000 employees
H1B Sponsorship
Contract Pharmacal Corp has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (2)
2023 (6)
2022 (5)
2021 (7)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Larry Lapila
Vice President of Business Development
Glenn Langberg
Chief Strategy Officer (CSO)
Recent News
Company data provided by crunchbase