QC Associate II

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

Job Title: QC Associate II
Location: Fremont, CA
Contract Duration: 6 Months

Duties:
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

Skills:
3-5 years of industry experience GMP experience is highly preffered
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
Education:
Bachelors' degree in Biology or Life Sciences required.