Job Description
The Manufacturing Specialist Investigations Lead will be the primary point of contact for leading investigations into deviations in fill/finish, inspection, and packaging operations.
Main Responsibilities:
* Manage deviation investigations, including establishing investigation teams, leading root cause analysis, developing CAPAs, and completing product impact assessments.
* Drive improvements to the investigation process.
* Present complex topics to large and small groups at various levels.
* Navigate through ambiguity and provide a structured problem-solving approach.
* Build effective relationships across functions.
Requirements:
* Bachelor's Degree in Science or Engineering with 5+ years of experience in biotech/pharma manufacturing or manufacturing support roles.
* Or Associate's Degree in Science or Engineering with 8+ years of experience in biotech/pharma manufacturing or manufacturing support roles.
* Detailed technical understanding of fill/finish operations.
* Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
Key Skills:
* Excellent technical writing.
* Excellent presentation and communication skills.
* Able to communicate and collaborate with technical and management staff.
* Flexibility and ability to manage change.