Quality Assurance Specialist IV

🌟 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!