Quality Engineer II

Quality Engineer

Overview: The Quality Engineer is tasked with ensuring that pharmaceutical manufacturing processes comply with regulatory standards set by the United States Pharmacopeia (USP), Food and Drug Administration (FDA), and Current Good Manufacturing Practices (cGMP). This role involves conducting thorough audits, inspections, and evaluations, leading investigations into quality issues, implementing corrective actions, and collaborating with various teams to enhance overall quality systems and drive continuous improvement.

Responsibilities:

• Conduct audits, inspections, and evaluations to ensure compliance with USP, FDA, and cGMP standards in compounding practices.
• Develop and review processes and documentation in line with cGMP requirements, including change controls and quality records.
• Lead investigations into deviations and complaints, utilizing root cause analysis to implement corrective actions (CAPAs).
• Collaborate with cross-functional teams to improve quality systems and provide compliance training.
• Review and approve technical transfer protocols, change controls, and quality records within the electronic Document Control System.
• Perform risk assessments to address quality issues, drive improvements, and support inspection readiness and audits.

Skills and Knowledge:

• In-depth knowledge of product investigations, CAPA processes, document control, change control, and cGMP regulations including USP <795>, <797>, <800>, and 21 CFR Parts 210, 211, and 11.
• Experience in sterile and aseptic manufacturing environments.
• Strong communication skills and ability to collaborate across functions.
• Proficiency in Six Sigma methodologies, lean manufacturing principles, Microsoft Office suite, and data analysis tools such as Excel or Minitab.

Experience and Qualifications:

• At least 2 years of experience in the pharmaceutical industry, including work on qualification protocols, validations, root cause analysis, compendial testing, and familiarity with FDA regulations and cGMP standards.
• Bachelor's degree in a scientific or engineering discipline.