Quality Analyst II - Exton, United Kingdom - TechAveev LLC
3 weeks ago
Description
Job Title :Quality AnalystII
Pay Rate:
$40.00/Hour on c2c (no otherbenefits)
Position Type:
Contract 1 year withextension
Location:
Exton PA UnitedStates
Description:
QC Analyst 2 willcontribute to the success of the operation by providing accurateGxPcompliant analyses of clinical biopharmaceutical products and byparticipating in assay qualification and validation studies.
Biopharmaceutical manufacturing runs typically cost in excess of 1$million each and reach many times that for larger phase 3 campaignswhile stability studies cost several hundred thousand dollars eachand this individual has an important role in ensuring that releaseand stability testing generates accurate results without delays orcompliance issues.
The individual will help maintain thebiochemistry laboratory systems assist in training other analystshelp maintain SOPs and other documents and promote an orderly andefficient laboratory workplace.
Education:
BS in biological or chemical sciences orequivalent
Experience:
Minimum of 24yrs working experience in a cGMP Quality Control analyticaldevelopment analytical transfer or validation department in aFDAregulated industry.
Knowledge ofprinciples concepts and practices in QC testing of proteinbiopharmaceuticals.
Handsonexperience with at least two techniques such as HPLC capillaryelectrophoresis ELISA or SDSPAGE used for analysis of recombinantproteins.
Knowledge of GxPrequirements and ICH/FDA/EMA guidelines.
Ability to identify and help investigate assay and equipmentproblems.
Fluent in English good written communicationskills; good interpersonal skills.
Team player who canexcel in a handson entrepreneurial environment.
Physicalrequirements:
handling of laboratory equipment chemicals andbiological materials.
Remarks:
We are looking for someonewith a few years of analytical lab experience with pharmmanufacturing inprocess release and stability testing that utilizestechniques such as HPLC ELISA Appearance capillary gelelectrophoresis.
PCR experience is a plus.