QC Associate II
eTeam · Fremont, CA · 2 mo ago
On-siteAnalystContract
About the role
This position provides expertise on routine and non-routine testing performed in QC laboratories of bulk drug substance and drug product in a multi-product facility. The role is responsible for technical review, interpretation, trending, quality review and investigation of atypical results.
Responsibilities
- 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, Osmolality, Microbiology and more
- Review analytical results within timeline right the first time
- Document work according to cGMP and cGDP
- Adhere to established regulations and follow cGMP established by site
- Report abnormalities and deviations in a timely and accurate manner
- Adhere to safety standards and identify unsafe situations / habits and escalate appropriately
- Maintain own training within compliance and assist other technicians and associates on operations upon completion of trainer qualification
- Represent QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments
Qualifications
- Bachelor's degree in Biology or Life Sciences required
- 3-5 years of industry experience
- GMP experience is highly preferred
Skills
- Strong interpersonal and communication skills (both written and oral)
- Strong customer focus, with an ability to interact with various departments and levels
- Ability to work independently and as part of a team to meet departmental/facility goals
- Ability to work across functions to achieve common goals
- Strong attention to detail, with an ability to focus on details of execution
- System familiarity that would be helpful: LIMS, Veeva & GoTrack