QA Lab Compliance Technical Lead - Branchburg, NJ
2 weeks ago
Job summary
This position independently works within the Celltrion Branchburg Process Team environment per Manufacturing Standards for Operational Excellence (MSOE), resolves key technical/quality problems and drives solutions that impact the site Leads medium-scale projects or programs with moderate risk and/or complexity This role ensures regulatory compliance and procedural consistency between manufacturing facilities prepares cross-functional partners for Regulatory Inspections Provides Quality Assurance presence in areas of responsibility by conducting periodic walkthroughsResponsibilities
- Evaluate deviations ensure appropriate root cause likely assignable cause(s) assess quality impact Recommend CAPAs ensure CAPAs implemented are effective Review approve respective development validation documentation Evaluate change controls associated risk assessments Perform training within group or throughout organization as needed Write escalate Notifications to Management as applicable Ensure timely completion of all quality plan objectives milestones Support on-time performance metrics Assist in creating quality metrics Keep Quality management informed of compliance issues Perform periodic walk-throughs area changeovers of Manufacturing facilities Assist activities associated with technology transfers from Celltrion Branchburg facilities as applicable Attend serve as a key resource in ad-hoc meetings to provide compliance guidance to Manufacturing Facilities Validation Computer Systems issues Support lot release through ensuring timeliness resolve of compliance issues as applicable Ensure compliance with applicable regulatory guidelines GxP computer systems global electronic records/signatures regulations 21 CFR Part 11 Annex 11 etc. as applicable Perform review regulatory submissions necessary Perform the compliance risk evaluation respective systems departments Participate internal audits performed by partners Celltrion Branchburg corporate regulatory agencies necessary Partner cross-functional groups management inspection readiness activities will interact FDA other regulatory agencies required Identify lead process improvement projects that impact systems used specific functional area Serve member Process Teams cross functional group charged making medicine continuous improvement site support accordance with Manufacturing Standards Operational Excellence Serve key Quality liaison disposition complying supporting lot release ensuring timeliness resolve issues necessary Analyze Audit Trail Reviews
Job description
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