Job Description:
Duration: 6 months+
The Scientist IV participates in new diagnostic product delivery from design verification through commercial launch. The candidate will partner with both internal and external manufacturing organizations from selection of the organization through process transfer. The candidate is expected to participate in a cross functional team consisting of representatives from Research and Development, Operations, Quality Assurance, and Regulatory Affairs.
General Duties & Responsibilities:
• Participate in the selection of external manufacturers and complete process transfer with preparation of request for quote and statement of work.
• Suggests improvements to methodologies, processes, products, and systems related to particular projects.
• Prepare formulation records, testing records, SOPs and risk management plans as necessary.
• Prepares protocols and reports, including quantitative analysis where necessary.
• Tests, analyses, and interprets data and events requiring evaluation in response to product support requests and manufacturing non-conformances.
• Maintains lab equipment and follows lab quality and safety requirements.
• Maintain aggressive timelines for completion of projects. Capable of multitasking.
• Works well cross-functionally and as a team member.
• Must work by strictly adhering to internal standard operating procedures and policies.
• Must work by strictly adhering to the regulations and guidelines of all applicable regulatory agencies, such as FDA (QSR/cGMP), OSHA, ISO (including ISO14001), J&J and OCD Health, Safety & Industrial Hygiene.
Qualifications:
• Typically will have a Ph.D. degree with post-doctoral experience and 3+ years performing progressively advanced duties or an MS degree and a minimum of 10 years of experience or a BS degree and a minimum of 15 years of experience performing progressively advanced duties beyond a B.S. degree, or at least 3 years of experience performing progressively advanced duties at the Senior Associate Scientist level, or the equivalent training/experience.
• Previous experience in product design and development following design controls is necessary.
• Experience with cGMP processes associated with reagent/biologics formulations is also necessary.
• Experience with six sigma methodologies will also be an advantage.
• Excellent interpersonal, teamwork and verbal/written communication skills will be necessary.
• Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously will be required.
Warm Regards,
NIMISHA DROACH
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012 & 2013 (7th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
(Direct) 732-429-1630
Tel: (732) 549 2030 x 226
Fax: (732) 549 5549
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.