Manufacturing Lead Investigator - Senior Job Summary
The Lead Investigators responsibilities will be to lead and manage new and aging investigations and related reports to closure within the established timelines for the engineering and 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. Job Responsibilities
Education & Qualifications
- 60% - Influence the organizational control of Quality systems: Create/monitor/author deviations, Out of Specification (OOS) and Out of Tolerance (OOT) and environmental alert actions. Monitor GMP investigations progress and support process to closure Escalate conflicts that arise.
- 20% - Work cross-functionally to assess and analyze deviations and investigations to determine impact and root cause
- 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
- Bachelors in Science or a related discipline with 5 years of industry experience in a pharmaceutical/biotech
- Minimum of 3 years related experience in the manufacturing of biologics, pharmaceuticals or devices preferred
- Previous technical writing experience preferred
- Strong written and verbal communication skills
- Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization
- Must be proficient with Microsoft Office applications, including Word, Excel and Power Point.
- Experience with more advanced document management applications a plus (including but not limited to TrackWise and SAP)
- 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 compliance
- Ability to apply industry regulations to decision making process
- Excellent presentation skills.
- Strong problem-solving skills and attention to detail
- 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.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.