We're Hiring: Quality Assurance Specialist IV!
We are seeking to hire a Quality Assurance Specialist IV in Newark, CA. A commercial
stage biotechnology company focused on innovative aesthetic, therapeutic and financial
technology offerings, setting a new standard in healthcare, is seeking a Quality Assurance
Specialist IV.
Location: Newark, United States
⏰ Work Mode: Work From Office
Role: Quality Assurance Specialist IV
Pay Scale: $100, 000 – $136, 869 (Dependent on Experience)
What You'll Do:
∙Provide technical writing in support of operational functions, such as Quality Control
(QC).
∙Responsible for authoring Out of Specification (OOS) and anomalous event laboratory
investigations, deviations, CAPA, and change controls.
∙Perform risk analysis as needed to determine severity, likelihood of recurrence when
triaging events and/or conducting investigations.
∙Conduct investigations thoroughly for OOS events according to the phase-based
approach per FDA and Annex guidelines.
∙Investigate deviations to identify root cause and contributing factors and in parallel
assess impact to patients, product quality, data integrity, validated state, and regulatory
compliance.
∙Identify and develop relevant and effective CAPA.
What We're Looking For:
∙Bachelor's in biology, biochemistry or related pharmaceutical-biotechnology discipline is
required
∙A minimum of 3 years work experience within a GMP environment working with small
and/or large molecules.
∙Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western
Blot, Karl Fischer, UV and HPLC (Waters Empower software is preferred), and Relative
Potency Assay.
∙Solid technical training and troubleshooting experience are essential.
∙Strong understanding of data integrity principles within a GMP environment is required
Ready to ensure excellence? Apply now and let's maintain quality together!