Quality Assurance Engineer

Job Summary

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, non-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.

About the Role

Join CPC, a company that has been setting the standard in pharmaceutical development and contract manufacturing since 1971. At CPC, we are committed to quality as a core value, innovative problem-solving, and a collaborative culture where everyone plays a role in advancing formulation and manufacturing excellence. We offer an inclusive, respectful workplace with opportunities to grow your skills and career while working with cutting-edge technologies and serving leading global brands.

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 events to identify systemic risks, recurring failure modes, and opportunities for process improvement.
• 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.
• 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.

Qualifications

• 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.).
• Able 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.

Pay

$80,000 - $110,000 per year, depending on experience

Schedule

Monday-Friday 8:00AM-4:00PM