Associate II, QC Technical

Summary

The Associate II, QC Technical is responsible for owning and facilitating Quality Control laboratory investigation processes within the quality management system (Veeva QMS), with activities prioritized according to business needs and timelines. The primary focus of this position is to collaborate with QC supervisors, leads, and analysts to plan, coordinate, and advance investigations; identify probable contributing factors and/or root cause(s) for laboratory incidents; and facilitate the timely completion, review, approval, and closure of investigation records to support critical business objectives. The role manages a variety of record types, including laboratory investigations, deviations, calibration events, and environmental monitoring alert, action, and adverse trend evaluations.

Responsibilities

• Facilitate and complete laboratory investigations (LIRs) for OOS, OOT, OOE, and system suitability/test acceptance failures, prioritizing activities according to product impact, compliance risk, operational urgency, and critical business need.
• Facilitate and complete deviation investigations related to QC laboratories and procedures, excursions, and adverse trends, prioritizing activities according to product impact, compliance risk, operational urgency, and critical business need.
• Serve as QC’s primary contact for documenting investigation findings and preparing trend or technical reports as necessary.
• Gather data, observe processes, and perform personnel interviews based on business priorities.
• Lead cross-functional root cause analysis using appropriate tools.
• Assign and prioritize child records based on risk, business need, and timelines.
• Align reviewers and SMEs on the investigation path and evolving priorities.
• Define appropriate CAPAs and effectiveness checks, providing ownership as needed.
• Identify trends and partner with appropriate teams for resolution.
• Define expected process impacts and monitor effectiveness with SMEs.
• Maintain QC investigations in compliance with company and regulatory standards.
• Partner with management and QA to prioritize and close QMS records within timelines aligned to business urgency as needed.
• Identify improvement opportunities and promptly escalate risks, barriers, or compliance concerns to appropriate management.
• Attend huddles as needed to provide investigation status updates and communicate support needs.
• Perform other assigned duties based on business needs and management direction.

Required Skills

• 6+ years’ experience working in a cGxP laboratory or related setting.
• Working knowledge of Root Cause Analysis (RCA) and Operational Excellence mechanisms.
• Knowledge with core chemistry principles and both microbiological and analytical methodologies such as purification, pH, bioburden, endotoxin, spectrophotometry, chromatography, ELISA, PCR, PAGE/CE, Activity and Enzyme Kinetics.
• High degree of accuracy and attention to detail.
• Strong written, particularly technical writing, and verbal communication skills.
• Strong time management, critical thinking, problem solving, decision making and leadership skills.
• Proficiency with QMS record and control document management software such as Veeva.
• Competence with usage of Microsoft Office Professional Suite (Word, Excel, PowerPoint, Outlook/Teams)

Desired Skills

• Demonstrated fluency of cGMP / GLP principles and industry standards throughout 8+ years of direct QC/QA operation involvement.
• Ability to dynamically manage multiple and complex priorities to meet changing business needs.
• Detailed experience with performing RCA as well as determining how appropriate remediations can be to interface with requirements of current processes and regulatory requirements.
• Experience with FDA, EP and/or JP regulations with some extent of previous responsibilities pertaining to audit preparedness.
• Exposure or participation of real-time process and test method performance monitoring.
• Deployment of baseline statistical principles and applications such as control limits, variance, regression analysis, outlier detection, variable frameworks for performance comparability.
• Knowledge of utilizing Microsoft Power Platform to increase operational efficiencies.
• Demonstrated passion for continuous improvement and readily working within a team-oriented and collaborative environment.

Education

B.S./B.A. degree in relative science disciplines (major in biology – biochemistry – chemistry preferred).