Manufacturing Lead Investigator

Title: Manufacturing Lead Investigator

Location: Lexington, MA

Duration: 8 Months+

Primary Duties: 

The Lead Investigators responsibilities will be to lead and manage all levels of deviations and related reports to closure within the established timelines for the manufacturing department. Will conduct comprehensive investigations to determine potential product impact, identify root cause and implementation of corrective and preventative actions in accordance with established procedures and timelines. 

Responsibilities: 

• 80% Create/monitor/manage/author deviations, Out of Specification (OOS) and Out of Tolerance (OOT) and environmental alert actions Monitor GMP investigations progress and support process to closure. 

• Work cross-functionally to assess and analyze deviations and investigations to determine impact and root cause. 

• Escalate conflicts that arise. 

• 10% Identify, initiate and track corrective and preventative actions for investigations, OOS and OOT 

• 10%Track and identify Quality System and root cause trends and identify opportunities for operational improvements 

Complexity and Problem Solving: 

• Ability to manage numerous priorities simultaneously Lead problem resolution meetings/teams effectively Ability to shift priorities to meet required deadlines 

• Effectively communicate issues cross-functionally in a timely manner Thorough understanding of biopharmaceutical manufacturing Comprehensive understanding of industry regulations and cGMP’s compliance

• Ability to apply industry regulations to decision making process 

• Excellent presentation skills. 

• Strong problem-solving skills and attention to detail Internal and External Contacts: Facilitates, consults and collaborates with cross-functional teams including but not limited to Facilities and Engineering, Manufacturing Sciences & Operations Support, Quality, Validation and Operational Excellence & Training and Health, Safety & Environment.

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