QC Associate II

• Provide expertise on routine and non-routine testing performed in QC laboratories of bulk drug substance and drug product in a multi-product facility.


• Responsible for technical review, interpretation, trending, quality review and investigation of atypical results.


• Assist with quality risk assessments, onboarding, qualification and implementation of non-routine, new equipment validation activties.


• Assist with implementing Client improvements and new ways of thinking toward lab processes and compliance activities.


• Assist and/or lead cross functional project team(s) responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls).


• Provide support during audits and inspections.


• Work independently with adequate training and background of fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, Osmolalilty, Microbiology and more.


• Review of analytical results within timeline right the first time.


• Documents work according to cGMP and cGDP.


• Adheres to established regulations and follows cGMP established by site.


• Reports abnormalities and deviations in a timely and accurate manner.


• Adheres to safety standards and identifies unsafe situations / habits and escalates approriately.


• Maintains own training within compliance and assist other technicians and associates on operations upon completion of trainer qualification.


• Represents QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments

• 3-5 years of industry expereince GMP experience is highly prefered


• Demonstrates strong interpersonal and communication skills (both written and oral)


• Strong customer focus, and an ability to interact with various departments and levels.


• Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals


• Able to work across functions to achieve common goals.


• Demonstrates strong attention to detail, and an ability to focus on details of execution.


• System familiarity that would be helpful: LIMS, Veeva & GoTrack

Bachelors' degree in Biology or Life Sciences required.