Transplant Diagnostics - Stamford, USA
Manufacturing Specialist - Diagnostics Kits - Biotech
We are a fast growing Biotech company and the leading provider of diagnostic products in the field of transplant immunology and genetic disease predisposition testing. Our facility is located in Southern Fairfield County, Connecticut.
As an integral member of the manufacturing team, the Manufacturing Specialist will assists with manufacturing production to ensure continuous production of products consistent with established ISO standards.
Principal Accountabilities:
· Formulates and maintains manufacturing objectives and coordinates with quality control to maximize product reliability, minimize costs and meet SBU and departmental productivity objectives.
· Performs production of all TLC products prior to sale or use, to ensure product quality and reliability. These may include, but is not limited to, Luminex based HLA typing kits and supporting reagents.
· Perform pre-shipment testing, in-process testing and inspection as required.
· Perform stability and validation testing
· Properly operate and appropriately maintain the equipment used in all job functions
· Document all manufacturing protocols and procedures to ensure organized and consistent laboratory testing activities
· Follow published Manufacturing Procedures and in accordance with ISO13485 and GMP
· Maintains Inventory controls and provides data input into Great Plains GRP.
Required Education, Skills and Experience:
· BS Degree in Biological Science and 3 + year’s laboratory or related experience OR MS Degree in Biological Science and 2 + years laboratory or related experience. Cell Culture experience a plus.
· Mathematical Skills: Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations. Ability to work with mathematical concepts such as probability and statistical inference.
· Computer Skills: Ability to use and manipulate Windows word processing and spreadsheet software and programs associated with equipment use to perform the duties of the job.
We offer a competitive benefits package which includes 3 weeks vacation, personal days and sick leave, medical, dental, Life, STD/LTD, 401(k), and a bonus program.
ONLY QUALIFIED APPLICANTS WILL BE CONTACTED AND ONLY LOCAL CANDIDATES WILL BE CONSIDERED.
Only those legally authorized to work in the Unites States can be considered.
PLEASE FORWARD RESUME AS A WORD ATTACHMENT WITH A COVER LETTER. Also, include current salary and salary requirements, send to: joanne.mcclellan@gen-probe.com
