Lead Investigator

Job description

Our client is looking for Lead Investigator – with the good manufacturing, cGMP, chromatography, bioreactor, cell culture, documentation etc., experience!!! RESPONSIBILITIES: • coordinating and leading the investigation process on all manufacturing and laboratory incidents related to all deviations including biomanufacturing process and equipment deviations and deviations for all analytical assays. • The candidate will be responsible for leading thorough, detailed and timely investigations and the generation of high quality and timely investigation reports detailing the root cause of the deviation and the preventive action that needs to be taken to prevent a reoccurrence. • As such the individual will be expected to develop mutually collaborative relationships with the operational leadership and staff in each of the manufacturing suites and the various quality control laboratories. • The candidate will be expected to have experience and in-depth understanding in the area of cell culture and bioreactor operations as well as protein chromatography and filtration. • It would also be highly desirable to have an understanding or awareness of the principles of quality assurance in a biological manufacturing environment and a working knowledge of compliance and the appropriate regulations. • Have detailed understanding of the processes and systems involved in the manufacture of bio pharmaceutical. • Be able to exercise appropriate judgment in developing practices, techniques and evaluation criteria for progressing an investigation in compliant manner. • Ensure their investigations are conducted with a strict adherence to appropriate quality and compliance standards. QUALIFICATIONS AND SKILLS NEEDED: • A BS or MS, preferably in a scientific or engineering discipline preferable. • A minimum of 2 years’ experience for an MS or 5+ years for a BS in a Biopharmaceutical and/or biological manufacturing operation with a strong technical background in the relevant scientific disciplines as well as cGMP and Quality environment is required. • Prior experience with investigations including conducting and writing investigations and in programs such as Operational Excellence and Six Sigma preferred. • The incumbent must be a collaborative team player with strong coordination, facilitation and writing skills. • Technical Writing, Data Research; interviewing as part of DMAIC; Six Sigma. Regards Pooja Mishra Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I Tel: 732 429 1636 (W) 732-549-2030 x 214 | (F) 732-549-5549 Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row) . A Few Words About Us 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. With todays growing demand for talented and well qualified professionals, its more important than ever to partner with a company that employs innovative measures to meet your demands. Our expert team of highly trained counselors work hand in hand with every client forming a partnership of understanding and commitment. Our clients know that they can rely on us for prompt response times and reliable staff to meet their workforce demands. Our employees know that they can trust our support for their career development and personal growth. IRI is proud to be JCAHO Certified by the Joint Commissions of Health, MBE Certified by the State of NJ and the National Minority Supplier Diversity Council (NMSDC) and SBE Certified by the State of NJ. We have been honored by the following: Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009 Top 500 Privately-Held Business in the US Top 500 Diversity Owned Business in the US Top 100 Subcontinent Asian American Business in the US We have also been listed to the Inc. 5000 List of fastest-growing, privately-held companies in the US in 2007, 2008, 2009 and 2010 and honored as an Emerging Business of the Year finalist by NJ BIZ in 2009.