VARITE is looking for qualified QC Associate II in Fremont, CA.
WHAT THE CLIENT DOES?A global, research-driven pharmaceutical company that focuses on developing innovative medicines in areas such as human pharmaceuticals, animal health, and biopharmaceutical contract manufacturing.
WHAT WE DO?Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.
Job Title: QC Associate IILocation: Fremont, CAContract Duration: 6 months (Possible Extension)Pay Rate Range: $32.97 - $35.32/hr on W2.Work Authorization: Only USC or GC
HERE’S WHAT YOU’LL DODuties: - 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 the 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 assists 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 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.
Education: - Bachelors' degree in Biology or Life Sciences required
BENEFITS: We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:
- Health Insurance: Medical, dental, and vision coverage
- Retirement Plans: Participation in a company-sponsored retirement savings plan.
- Legal Service Plans: Offering access to attorneys for legal advice and representation.
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VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.