Science and Compliance Specialist

Responsibilities

• Lead and execute investigations for deviations, including defining scope, applying structured problem-solving methods, and documenting results in compliance with cGMP standards.
• Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools.
• Investigate the root cause(s) of the issue and document the investigation results.
• Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle.
• Collaborate with Action Owners to create effective Corrective and Preventive Action (CAPA) plans and support verification of CAPA effectiveness.
• Manage multiple investigations simultaneously, ensuring timely progression and compliance with deadlines.
• Represent operations during audits and inspections by clearly explaining investigation scope, rationale, findings, and supporting data.
• Review and analyze operational data to identify trends, recurring issues, and opportunities to reduce downtime, increase yield, and improve operator efficiency.
• Partner with Process Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall process performance.
• Serve as an operations subject matter expert (SME), providing technical guidance on process performance, aseptic practices, and equipment operation.
• Draft, revise, and approve Standard Operating Procedures (SOPs) and other controlled documents to ensure accuracy, clarity, and compliance with regulatory expectations.

Requirements

• BS degree, preferably in a science or technical area or equivalent aseptic pharmaceutical manufacturing experience.
• 2+ years technical writing experience, preferably in pharmaceutical industry.
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Knowledge of applicable CAPA procedures, specifications, regulations and standards.
• Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency.
• Goal-setting, prioritize, organization, attention to detail, and time management skills.
• Critical & creative thinking and problem-solving skills.
• Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data.
• Strong oral and written communication skills.
• Ability to demonstrate strong leadership skills.
• Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP).
• Ability to utilize enterprise software systems (Veeva).

Physical / Safety Requirements

• Duties will require overtime work, including nights and weekends on occasion.
• Ability to gown in C/D gowning area.