The candidate will be responsible for performing Quality Control testing on
raw materials, in-process, finished product, and stability samples in
support of timely release. The responsibilities of the position include
testing, equipment calibration and maintenance, updating documents (STP's,
specifications, and SOP's), general laboratory maintenance, participation in
laboratory safety audits, and maintenance of cGMP in the QC laboratory.
Previous experience with proteins is a plus.
Essential Requirements of Position:
Perform HPLC testing on in-process, release and stability samples 50%
Reviewing analytical data 10%
Technical Writing (SOP's, STP's, Specifications, Protocols etc.) 10%
Perform USP/NF/ACS/EP wet chemistry analyses 10%
Calibration and maintenance of equipment 10%
General QC laboratory duties (safety audits, glassware, cleaning etc.) 10%
Core Competencies:
A minimum of five years relevant Quality Control experience is required for
the Associate Scientist position, and 8-10 years relevant Quality Control
Experience for the Scientist position.
A Bachelors or Masters degree in Chemistry or a related science is required.
The candidate must be familiar with the following:
HPLC assays (Ion Exchange, Gel Permeation Chromatography, and Reverse Phase)
Gas Chromatography
General validation of analytical equipment (Operational Qualification and
Performance Qualification)
General wet chemistry techniques
Data acquisition systems (preferably Chemstation)
Familiarity with Microsoft Word and Excel
Familiarity with LIMS is a plus
Good organizational skills
Ability to meet deadlines
Send resumes to:
Ron Sperling
Rm 2022, PDC
Q.C. Ortho Biotech
Route 202
Raritan, New Jersey 08869-0602
Phone (908) 218-6293
fax (908) 707-3563