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Quality Assurance Engineer

Contract Pharmacal Corp — Contract Pharmacal Corp. (1)

Posted 2026-09-26, as stated by the employer. Pay, in the employer's own words and neither converted nor estimated: $80,000 - $110,000 per year.

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The employer's own 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.

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Pulled straight from Contract Pharmacal Corp's own hiring system — never an aggregator, never a repost. A dated posting is served for at most 30 days from the date the employer states, and is dropped the moment their feed stops serving it. This page was built 2026-09-27.