QC Associate

Pay: $33.19/hour

Duration: 6+ months
Schedule: 1st Shift, Monday–Friday, 9 AM–5 PM

Overview

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 client 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, out-of-specification (OOS) results, corrective and preventive actions (CAPAs), and change controls). Provide support during audits and inspections.

Work independently with adequate training and background in fundamental operations such as biochemistry, drug product device testing, UV-Vis absorbance, gel electrophoresis, osmolality, microbiology, and more. Review analytical results within timelines right the first time. Document work according to current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP). Adhere to established regulations and follow cGMP standards. Report abnormalities and deviations in a timely and accurate manner. Adhere to safety standards, identify unsafe situations or habits, and escalate appropriately. Maintain personal training compliance and assist other technicians and associates upon completion of trainer qualification. Represent QC operations on cross-functional root cause analysis teams for deviations, CAPAs, and risk assessments.

Requirements

• 3–5 years of industry experience
• GMP experience is highly preferred
• System familiarity that would be helpful: LIMS, Veeva, and GoTrack
• Bachelor’s degree in Biology or Life Sciences required