Senior Scientist, QC Compliance

Position Summary

Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs and change control. Represent department in internal/external inspections. May author responses to regulatory requests and inspection and may support authoring of APQR sections for QC.

Duties/Responsibilities

• Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs and change controls.
• Apply technical and compliance knowledge of regulatory requirements to conduct root cause analysis and laboratory investigation on non-routine complex investigation.
• Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls.
• Generate and report KPIs. Highlight and escalate at risk items.
• Analyze and report CAPA effectiveness.
• Own document revision, projects, CAPA and deviation/investigation, change management and/or continuous improvement efforts.
• Train and mentor others on deviation, investigation, CAPA and change control process/procedures.
• Represent department in internal/external inspections.
• May author responses to regulatory requests and inspections and represent the department in governance & review boards.
• May support authoring of APQR sections.
• Communicate effectively with management and cross functional teams (e.g., present investigation findings at governance forums).
• Perform other tasks as assigned.

Qualifications

Specific Knowledge, Skills, Abilities: Advanced ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Advanced problem-solving ability/mentality, critical thinking, technically adept and logical. Advanced ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs. Ability to work in a fast-paced team environment, action oriented, highly organized to meet deadlines and prioritize work from multiple complex investigations and projects. Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.

Education/Experience/Licenses/Certifications: Bachelor's degree in science, engineering, or related discipline. Advance degree preferred. 8+ years of experience in biopharmaceutical or QC lab operations with 2+ years of prior investigation experience required. An equivalent combination of education and experience may substitute. Knowledge of analytical and microbiological testing preferred. Demonstrated advanced experience with Quality management systems. Demonstrated advanced technical writing skills. Demonstrated advanced experience in laboratory or biomanufacturing investigations and root cause analysis techniques.