QC Associate II

Position Title: QC Associate II
Work Location: Fremont, CA 94555
Assignment Duration: 6 Months
Work Schedule: 1st Shift: Mon-Fri, 9AM-5PM

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

Key Responsibilities:

• 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 activities.
• Assist with implementing novel 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 appropriately.
• 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

Qualification & Experience:

• 3-5 years of industry experience GMP experience is highly preferred
• 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.