Job Summary:
The company is seeking a Deviation Investigation Specialist to support pharmaceutical manufacturing operations in a GMP-regulated environment. This role is responsible for leading and authoring deviation investigations, performing root cause analysis, assessing product impact, and implementing effective corrective and preventive actions. The position requires strong technical expertise in oral solid dosage manufacturing, cross-functional collaboration, and technical problem-solving.

Key Responsibilities:

• Lead and author cGMP deviation investigations, nonconformances, and atypical event reports for manufacturing and laboratory operations.
• Coordinate event triage activities, containment actions, escalation processes, and support batch disposition decisions.
• Collect, organize, and analyze manufacturing, engineering, laboratory, and equipment data to identify root causes and contributing factors.
• Facilitate structured root cause analysis using methodologies such as 5 Why, Fishbone, and Fault Tree Analysis.
• Develop, document, implement, and monitor corrective and preventive actions to prevent recurrence of quality events.
• Prepare accurate technical reports, investigation records, and product impact assessments in accordance with Good Documentation Practices.
• Support continuous improvement initiatives, investigation trending, and audit readiness activities.
• Collaborate with Manufacturing, Quality, Engineering, Regulatory, and Laboratory teams to resolve complex technical issues.
• Evaluate equipment performance, process parameters, and manufacturing trends to support risk-based decision making.
• Maintain compliance with GMP requirements, quality systems, and data integrity expectations.

Required Qualifications:

• Bachelor’s degree in Chemistry required.
• Master’s degree in Science or Engineering preferred.
• Experience supporting pharmaceutical manufacturing investigations in a GMP-regulated environment.
• Strong knowledge of oral solid dosage manufacturing processes, including blending, granulation, compression, coating, and encapsulation.
• Experience leading deviation investigations, root cause analysis, CAPA development, and effectiveness monitoring.
• Strong technical writing and documentation skills.
• Knowledge of cGMP requirements, pharmaceutical quality systems, and data integrity principles.
• Experience working with electronic quality systems and manufacturing data systems.
• Ability to analyze manufacturing, equipment, and laboratory data to identify trends and technical solutions.
• Excellent verbal and written communication skills with the ability to collaborate across multiple departments.
• Strong analytical, critical thinking, and problem-solving abilities.

Preferred Qualifications:

• Experience supporting commercial pharmaceutical manufacturing operations.
• Exposure to process validation, technical transfers, automation, or digital manufacturing tools.
• Experience with MES, LIMS, eQMS, historian systems, and data trending tools.
• Lean, Operational Excellence, Green Belt, or Black Belt certification.
• Experience supporting audit and regulatory inspection readiness activities.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $40/hr to $45/hr