Lead QA Investigator

About the role

Location: Bedford, Ohio. Job Type: Full-time.

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated [Job Title] to join our team.

Responsibilities

• Leading, coaching, and mentoring direct reports to accomplish organizational and department priorities.
• Overseeing, assigning, reviewing, and approving investigations from atypical events in-house, critical complaints, or inter-company complaints focusing on CAPA and disposition of the lot(s) affected within 30 days of notification.
• Managing staff of investigators on assessment of criticality, determination of affected batches (starting materials, bulk and finished product, root cause analysis, processes, assignment of CAPA, and leading technical meetings.
• Escalates quality and compliance issues to quality leaders as appropriate.
• Regular and predictable onsite attendance and punctuality.
• Leads the Investigation groups (QAI and Product Complaints.
• Responsible for deviations to ensure each event is classified correctly, all impacted materials are evaluated.
• Investigations are documented thoroughly and consistently.
• Use appropriate problem-solving techniques and process analysis to ensure determination of root cause and CAPA assignment.
• Provides timely feedback back to ensure continued growth of the team.
• Documents performance gaps and initiates intervention strategies up to and including disciplinary action.
• Anticipates and resolves obstacles having the potential of negatively impacting supply chain performance and or compliance.
• Communicates goals and results to key stakeholders including but not limited to direct reports, management, and peers.
• Oversees the development, monitoring and maintenance of QA investigation standards, processes, and procedures.
• Ensures the Problem-Solving Training is sustainable.
• Reviews and approves investigations from atypical events in-house, major/critical complaints, or inter-company complaints focusing on CAPA and disposition of the Lot(s) affected within 30 days of notification and ensures quality meets acceptable standards.
• Ensures staff conducts investigations according to procedures and processes.
• Acts as a quality liaison with the supply chain through appropriate meetings (P2P, etc.), regulatory authorities during inspections and business partners (corporate or customer) for relevant investigations.
• Acts as a quality liaison with Quality Control and Analytical Development to review phase I laboratory investigations and initiate phase II laboratory investigations.

Qualifications

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Up to Five (5) years of pharmaceutical, Chemical, or Food industry experience in Manufacturing, Quality, or Compliance is required
• At least three (3)