QC Associate II

WillHire; Fremont (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

WillHire in Fremont, CA seeks a QC Laboratory Analyst to perform routine and non-routine testing in a multi-product facility, review results, and support investigations within cGMP guidelines.

The role requires 3-5 years of GMP experience, strong communication, and a Bachelor's degree in Biology or Life Sciences. Collaboration with multiple departments and adherence to safety and quality standards are essential.

Qualifications

• Bachelor's degree in Biology or Life Sciences is required.
• 3-5 years of GMP experience preferred.

Responsibilities

• Review analytical results and ensure cGMP compliance.
• Investigate deviations, out-of-spec results (OOS), CAPAs, and risk assessments.
• Support audits and inspections.
• Lead or participate in cross-functional project teams for QC-related deliverables.

Skills

Interpersonal skills

Communication skills

Attention to detail

Team collaboration

Independent work

Customer focus

Education

Bachelor's degree in Biology or Life Sciences

Tools

UV-Vis absorbance

Gel electrophoresis

Osmolality measurement

Microbiology assays

Job description

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 activties. 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 CAPAsand 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 approriately. 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

3-5years of industry expereince GMP experience is highly prefered Demonstrates strong interpersonal and communication skills (both written and oral), a 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; is also able to work across functions to achieve common goals. Demonstrates strong attention to detail, and an ability to focus on details of execution

Bachelors' degree in Biology or Life Sciences required.