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:
Qualification & Experience:
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.
QC Associate II in fremont at Unknown Company
This position is listed as full time and onsite.