Job Description

Position: Pharmaceutical Quality Investigator
Location: West Point, PA (Onsite)
Duration: 12 Months

Seeking a  Pharmaceutical Quality Investigator to provide scientific and technical expertise in a state-of-the-art manufacturing environment. This role focuses on managing and reducing process deviations, performing root cause analyses, and implementing corrective and preventative actions (CAPAs). The ideal candidate will leverage their scientific knowledge and problem-solving skills to ensure quality and compliance in manufacturing operations.

• Provide technical support for manufacturing operations, ensuring prompt resolution of process deviations.
• Lead investigations into manufacturing and laboratory deviations, emphasizing root cause identification and CAPA development.
• Collaborate with cross-functional teams across aseptic manufacturing, testing, planning, and release processes.
• Troubleshoot real-time laboratory test failures and manufacturing atypical events, ensuring thorough understanding of product impact and resolution.
• Apply scientific and engineering principles to analyze and address complex issues via laboratory/pilot-scale experiments.
• Document findings and solutions in compliance with cGMP standards.

• Bachelor’s or Master’s degree in Mechanical Engineering, Chemical Engineering, or a related scientific field.

Industry Expertise:

• 0-3+ years of experience in a cGMP environment (e.g., production, development, process engineering, technical services) within the pharmaceutical or biotech industry.

Deviation Management:

• Hands-on experience with deviation investigations, vaccine operations, or related project work.

Technical Skills:

• Proficiency in writing investigations for atypical manufacturing events.
• Experience troubleshooting biotech equipment, barrier technology, and closed system processes.
• Familiarity with systems like MIDAS and SAP.
• Ability to interpret Piping and Instrumentation Diagrams (P&IDs).

Lean Six Sigma:

• Knowledge of Lean Six Sigma methodologies, with strong analytical and problem-solving abilities.

Communication and Collaboration:

• Exceptional written and verbal communication skills to present findings clearly.
• Demonstrated ability to work both independently and as part of a cross-functional team.

• Strong expertise in deviation management and root cause analysis.
• Excellent investigation writing skills with a focus on detail and clarity.
• Effective time management to handle deadlines and deliverables in a fast-paced environment.
• Flexibility to adapt to dynamic manufacturing processes while maintaining quality and compliance.

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