Quality Assurance Engineer

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.