Senior Manufacturing Lead Investigator
Shire Pharmaceuticals is seeking a full-time temporary (contract) Senior Manufacturing Lead Investigator. The incumbent will lead and manage major/critical 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. 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.
This position is contract, 40 hours per week for 6 months, pending review of resourcing needs at that point.
- Influence the organizational control of Quality systems (60% time):
- Create/monitor/author deviations, Out of Specification (OOS’) and Out of Tolerance (OOT’s) and environmental alert actions
- Monitor GMP investigations progress and support process to closure
- Escalate conflicts that arise.
- Work cross-functionally to assess and analyze deviations and investigations to determine impact and root cause (20% time)
- Identify, initiate and track corrective and preventative actions for investigations, OOS and OOT (10%) time)
- Track and identify Quality System and root cause trends and identify opportunities for operational improvements (10% time)
- Bachelor’s 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
For consideration, please send resume and cover letter directly to Dori Parmelee, HR Manager (email@example.com). *Recruitment agency candidates are not accepted for this position. Please do not contact.