Quality Control Stability Analyst

QC Stability Analyst

 

Position Description:

You will be responsible for coordination of product contract testing, implementation and maintenance of stability protocols and studies for a variety of developmental, clinical and commercial products. 

 

Responsibilities include:

 

?  Sample requisition and distribution to contract test laboratories and internal test groups 

?  Preparing samples prior to distribution utilizing pipets, balances or biological safety cabinets and aseptic laboratory techniques

?  Performing comprehensive review, tabulation and assessment of data (including trending and OOS investigations) as well as preparation of formal data reports

?  Participating in required maintenance of storage equipment within the QC Stability group

 

Requirements Include:

?  BS/BA and 3+ years experience in a Quality Control laboratory performing analytical assays such as HPLC and SDS-PAGE 

?  Knowledge of protein stability and a good understanding of cGMPs

?  An understanding of biologics testing, stability testing and requirements, and knowledge of FDA, ICH, and applicable stability regulations are a plus

?  Computer skills in MS Word, EXCEL, 4th Dimension and JMP are desirable.

?  Strong interpersonal and communication (written and oral) skills and the ability to work well in a team environment are essential