Sr. Associate, Quality Control – Analytical

The Senior Quality Control Associate will be responsible for performing multiple tasks within the Quality Control (QC) group in support of GMP manufacturing activities. Focus areas include execution of analytical method qualification/validation protocols, routine analytical testing and documentation/data review of QC generated results.  The position requires extensive experience within a QC setting and detailed knowledge of GMP/GDP.  The associate will perform a variety of responsibilities in both a team and individual setting. 

Responsibilities  

• Provides critical QC centric review of draft Analytical Test Methods (ATMs) and qualification/validation protocols received from the Analytical Method Development (AMD) group. 
• Leads the execution of qualification/validation protocols and writes technically sound qualification/validation reports. 
• Leads the implementation of programs (e.g. evaluation/implementation of compendial testing). 
• Demonstrates a working knowledge of compendia testing (USP, Ph. EUR, JP, etc.) wet chemistry techniques and analytical analysis (U/HPLC, GC, FTIR, KF, etc.). 
• Performance of QC raw material, in-process, and bulk drug product testing, as well as support of testing/review of data with/from contract testing laboratories (e.g. compendial methods, HPLC, fluorescence assays, particle sizing, bioburden, and endotoxin, etc.) 
• Provides expert review of QC data and associated documentation. 
• Leads laboratory investigations to determine root cause for OOS, OOT, Atypical and invalid test results. 
• Contributes to laboratory operations by performing regular instrument calibration and minor instrument maintenance. 
• Support operational systems (e.g. equipment maintenance, reagent preparation, forms control, etc.). 
• Operate to the highest ethical and moral standards. 
• Comply with Abzena’s policies and procedures. 
• Communicate effectively with clients, supervisors, colleagues and staff. 
• Participate effectively as a team player in all aspects of Abzena’s business. 
• Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. 
• Perform other related duties as assigned. 

Requirements: 

• B.S. in applicable science field 
• A minimum of 5-7 years of relevant Quality Control industry experience in a GMP laboratory setting. 
• In-depth knowledge of the theoretical and practical aspects of analytical methods utilized to characterize large molecule therapeutics including: U/HPLC, CE, cIEF, ELISA, SDS PAGE and all compendial testing 
• Experience with the transfer and qualification/validation of large molecule focused analytical methods. 
• Experience with authoring, reviewing and approving analytical test reports, qualification/validation protocols, qualification/validation reports and SOPs. 
• Knowledge of compendia (USP, Ph. EUR, and JP) and ICH guidelines. 
• Strong written and oral communication skills, proficient with Microsoft Office software. 
• Data Trending and control chart interpretation. 

Travel between Abzena sites (Bristol PA, San Diego CA and Sanford NC) will be required.    

Physical Requirements:    

•  Frequently lift and or move objects up to 20 pounds.  
• Stand/walk during entire length of shift.  
• Use of arms, hands and fingers to handle, feel or reach.  
• Ability to climb, balance, stoop, kneel, crouch, or crawl.  
• Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.