Manufacturing Compliance Specialist

• Lead deviation investigations and root cause analyses to identify, document, and resolve manufacturing and quality events.
• Demonstrate strong technical problem-solving capabilities and excellent technical writing skills to support compliance documentation and investigations.
• Drive continuous improvements in processes and methods that reinforce cGMP within the department and/or across the site
• Partner with cross-functional stakeholders to identify, develop, and implement effective Corrective and Preventive Actions (CAPAs) that prevent recurrence of deviations and address underlying issues.
• Analyze and trend deviations, CAPAs, and compliance metrics to identify recurring issues, emerging risks, and opportunities for improvement.
• Develop and implement novel approaches to solving non-routine technical and compliance challenges.
• Communicate information effectively through updates, reports, and summaries.
• Support and participate in internal audits, client audits, and regulatory inspections conducted by global health authorities.
• Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems
• Collaborate with operational teams to implement process improvements while maintaining regulatory compliance.
• Support GMP training or knowledge sharing initiatives to foster a culture of quality, compliance, and continuous improvement.
• Provide routine updates on campaign, project, and investigation status, including risks, challenges, and mitigation plans.
• Provide support and/or direction to junior staff when necessary
• Exercise sound judgment and make data-driven decisions within established quality and compliance frameworks.
• Make critical decisions in collaboration with key stakeholders
• Demonstrate accountability for personal, departmental, and organizational initiatives.

• BA / BS in a science or engineering related discipline (Biology, Chemistry, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering)
• minimum 4-6 years of experience or an Associate’s degree and a minimum of 10 years of experience in a GMP manufacturing environment
• Previous hands-on experience in a regulated (eg:GMP/Aerospace) operations environment
• Experience in investigating and helping to resolve production non-conformances, implementing CAPA/Change Controls and leading improvement projects
• Strong proficiency in Microsoft Word, Excel, Power Point
• Familiarity with electronic quality management systems (eQMS) such as Veeva, Track Wise, Master Control, or similar platforms.
• Strong knowledge of cGMP regulations, FDA regulations, ICH guidelines, data integrity principles, and quality risk management practices.
• Strong leadership, organizational, communication, technical and writing skills.

Demonstrates strong technical problem-solving and writing skills to support compliance documentation and investigations, while driving continuous improvements in processes that reinforce cGMP standards. Possesses extensive experience in investigating deviations, implementing CAPAs, and collaborating with cross-functional teams to enhance quality and compliance.

• GMP Manufacturing Experience
• CAPA Implementation
• Technical Problem-Solving
• CGMP Regulations Knowledge
• Electronic Quality Management Systems (eQMS)

• Root Cause Analysis
• Deviation Investigation
• Data Analysis
• Technical Writing
• Process Improvement

• Leadership
• Communication
• Organizational Skills
• Judgment
• Collaboration

• CGMP
• FDA Regulations
• ICH Guidelines
• Quality Risk Management
• Data Integrity Principles

• Microsoft Word
• Microsoft Excel
• Microsoft Power Point
• Veeva
• Track Wise
• Master Control