Quality Systems Engineer

Contract Pharmacal Corp; Hauppauge (NY); On-site; USD 80,000 - 110,000; Full time

Job summary

Contract Pharmacal Corp in Hauppauge, NY, is looking for a Quality Systems Engineer to enhance quality system activities. Your primary responsibilities will include leading quality event investigations and implementing corrective actions.

The ideal candidate will possess a Bachelor's degree in a related field and at least 5 years of experience in Quality Assurance or Quality Engineering within a regulated environment. Strong technical writing and analytical skills are essential.

We offer a full-time position with a competitive salary range of $80,000 to $110,000 per year based on experience.

Qualifications

• 5 or more years of experience in Quality Assurance or Quality Engineering in regulated environments.
• Certifications in Six Sigma, Root Cause Analysis, cGMP are preferred.
• Experience in leading quality event investigations and CAPAs.

Responsibilities

• Lead quality event investigations and ensure documentation meets regulatory standards.
• Drive development of risk-based CAPAs.
• Support inspection readiness and audits.

Skills

Technical writing skills

Data analysis proficiency

Root cause analysis

Knowledge of cGMPs and FDA regulations

Risk-based decision-making

Education

Bachelor’s degree in relevant field

Tools

Minitab

Microsoft Office Suite

Job description

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.

Requirements

• 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.