Summary
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.
Job Function and Description:
• 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
Key Skills, Abilities and Competencies: 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)
Education & Experience:
Bachelors in Science or a related discipline with 5 years of industry experience in a pharmaceuticals. Minimum of 3 years related experience in the manufacturing of biologics preferred. Previous technical writing experience preferred.
Warm Regards,
Jay Kaushik
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
Direct: (732) 429 1633
Tel:(732) 549 2030x211
Fax: (732) 549 5549
http://www.irionline.com
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.