Quality Control Associate 2

Salary Range: 50000 to 80000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

• Performance of QC raw material, in-process, drug substance and drug product testing for release and stability, as well as support of testing/review of data with/from contract testing laboratories (e.g. compendial methods, HPLC, ELISA, CE, fluorescence assays, particle sizing, bioburden, endotoxin, etc.).
• Provides critical QC centric review of draft Analytical Test Methods (ATMs) and qualification/validation protocols received from the Analytical Method Development (AMD) group.
• Executes qualification/validation protocols and writes technically sound qualification/validation reports.
• Participate in method and equipment qualification and validation in the QC laboratory.
• Provide review of QC data and associated documentation.
• Support laboratory investigations to determine root cause for OOS, OOT, Atypical and invalid test results.
• Contribute to laboratory operations by performing regular instrument calibration and minor instrument maintenance.
• Support operational systems (e.g. equipment maintenance, reagent prep, forms control, etc.).
• Train on all relevant procedures, as appropriate.
• Operate to the highest ethical and moral standards.
• Demonstrate flexibility with changing priorities.
• Apply a working knowledge of compendia testing (USP, Ph. EUR, JP, etc.) wet chemistry techniques and analyticalanalysis (U/HPLC, CE, cIEF, ELISA, SDS PAGE, etc.).
• Contribute to Quality Control department goals and objectives.
• 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.

Qualifications

• B.S. or Associates and Certificates plus 2 years’ experience.
• 2-5 years of experience in a GMP Laboratory setting.
• 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 preparing analytical test reports, qualification/validation protocols, qualification/validation reports and SOPs. 
• Familiarity with compendia (USP, Ph. EUR, and JP) and ICH guidelines.
• Strong written and oral communication skills, proficiency with Microsoft Office software.