Previous Job
Previous
Quality Control Chemist - Branchburg, NJ
Ref No.: 20-00259
Location: East Brunswick, New Jersey
Position Type:Direct Placement
 Responsibilities Include:
1.      Conduct physical and chemical analysis of raw materials / in-process / semi-finished goods / finished goods / stability and complaint samples.
2.      Utilize the appropriate equipment in the QC laboratory for analyses, including those used for chromatographic, spectroscopic and wet chemical analyses.
3.      Qualify, calibrate, maintain and troubleshoot equipment in the QC laboratory.
4.      Conduct analysis by strictly following the written and approved documentation (SOPs, STPs, Specifications, Protocols, etc.).
5.      Perform analysis and generate data in a manner provided by TKU procedures, processes and systems to maintain data integrity and easy traceability.
6.      Work with QC Manager and QA to meet training requirements, investigate OOS/OOT/Deviations results, perform Changes Controls and resolve CAPAs.
7.      Perform analyses and other duties in a timely manner, regularly meeting site timing expectations.
8.      Direct or participate in Method Transfers from R&D to TKU. 
9.      Perform analysis to be included in filing ANDA and NDA submissions to FDA. 
 
Qualifications Include:
1.      BS in Chemistry, advanced degree preferred.
2.      5 or more years of experience within quality control or a development laboratory. Experience in pharmaceuticals highly preferred and beneficial.
3.      Working cGMP knowledge required.
4.      Experience in a laboratory supporting manufacturing operations highly beneficial.
5.      Knowledge in operation of general lab equipment.
6.      Be a problem solver and prioritize daily/weekly needs to meet shipment schedules are essential. Ability to effectively multi-task essential.
7.      Proficiency in a windows-based environment including word processing, spreadsheet and data base programs. Knowledge in SAP highly beneficial.