ABOUT US

At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals.

POSITION SUMMARY

cGMP Consulting is seeking a motivated and detail-oriented individual to support the Quality Assurance department for facilities, systems, and processes as part of dynamic expansion project. This individual must have the ability to write reports clearly, concisely and accurately. The ideal candidate will excel in leading cross-functional collaboration, timely reviews of documents, MOCs, deviations and other GMP documents while demonstrating independence. This candidate should have a strong understanding of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.

REQUIREMENTS

• Bachelors’ degree in Engineering, Science, or a related field of study.
• 2-4 years’ experience in a GMP manufacturing environment specifically with quality assurance.
• Experience in aseptic qualification and validation practices.
• Knowledge of cGMP practices including Good Documentation Practices, and familiar with regulatory (FDA) requirements.
• Strong organizational, communication, and interpersonal skills.
• Experience with deviation management systems and technical writing for investigations.

The essential functions include, but are not limited to the following:

• Evaluates and reviews project documents related to facilities, utilities, maintenance and equipment. These documents include, but not limited to, Design Qualification, Installation Qualification, Operation Qualification, Performance Qualification, Risk Assessments and Gap Assessments, Factory and Site Acceptance Tests.
• Provide proactive QA support during manufacturing operations.
• Provide compliance direction to cross-functional groups to ensure conformance and compliance to Company Policies and Procedures and regulatory standards.
• Lead or support root cause investigations and implement effective CAPAs.
• Conduct technical reviews of deviations to ensure correct documentation, sound rationale and regulatory alignment.
• Provide quality oversite for batch record reviews, and other manufacturing documentation.
• Support inspection readiness activities and ensure documentation is audit-ready.
• Track and report key quality metrics (deviation closures, CAPA effectiveness, document review turnaround).
• Draft, review and update standard operating procedures (SOPs) related to QA activities and compliance.
• Support supplier qualification and audits, including review of quality agreements and assessments.
• Monitor and ensure data integrity practices in paper-based records.
• Maintain compliance with company policies, training requirements, cGMP standards, and safety protocols.
• Utilize Word, Excel, Document Management Systems, and other electronic tools to complete tasks efficiently.
• Perform additional tasks or duties as assigned by management.