Duration: This position is covering for an FTE that will be going on maternity leave. However, this department is experiencing a lot of growth and they are considering it to be a contractor to hire opportunity.
Manager is looking for a MICROBIOLOGIST- not a chemist. Must have pharma experience and GMP- 2-3 years of it. Not looking for someone that worked in a non-regulated environment, they will NOT be a good fit for this opportunity.
SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
" Under the supervision of other scientists, works on problems of limited scope where analysis of data requires evaluation of identifiable factors. Demonstrates potential for technical proficiency and scientific creativity.
" Under the supervision of other scientists, carry out activities in support of the manufacturing of pharmaceutical products. These activities include compendia! microbial testing of raw materials, in process materials, and finished products within scheduled timelines.
" Perform environmental sampling and testing.
" Perform USP water sampling and testing.
" Perform identification of microorganisms.
" Maintain notebooks within GMP standards and SOPs. Accurately report results, and provide detailed records of results and conclusions.
" Provides written and verbal updates on projects and activities as required.
" Is familiar with Quality Systems such as: Compliance Wire, Trackwise , Documentum.
" Assist other scientists, as necessary, for timely project completion and support other lab personnel as required.
" Comply with Health, Safety and Environmental responsibilities for the position.
" Other tasks as assigned.
POSITION REQU IREMENTS:
Education: MS/BS Chemistry/Pharmacy or AA with equivalent experience
Experience: 0 (MS) -5 years applicable industry experience preferably in pharmaceu tical microbiology
Knowledge/Sk ills: Working knowledge and application of scientific principles and aseptic techniques . General knowledge of compendia! microbiology requirements. Experience with computer software associated with word processing and spreadsheets
Supe rvises: None
" Physical/ Mental Requirements: Mathematical and reasoning ability
" Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
" Abil ity to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds. Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
Work Environment: Individual's primary workstation is located in the laboratory area, where the noise level is low. Employee may be present on the manufacturing floor where the noise level is low to moderate.
113 14 Schoolhouse Road (phone number removed) Somerset NJ 08873 United States
Additional Job Details: