Quality Control Expert, QA Operations

Summary

Location: Millburn, NJ #onsiteThe Quality Assurance for Quality Control Expert, QA Operations will serve as the sole QA for QC SME, managing all activities related to QC at the Millburn, NJ Site. This role will provide QA oversight of all testing of intermediates in process control, microbiological/EM program product release, raw materials release stability sample testing and release for production support (as required) and documentation to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements.

About the Role

• Establishes/implements quality systems with Quality Control Operations; Provides and manages QA oversight of QC operations through review/approval of test records for batch release, SOPs, C of As (as applicable), CAPAs, Deviations, change controls, analytical protocols and reports
• Provides the QC team with QA/Compliance guidance and decisions; Set up and maintain standards in providing the QC team with QA guidance and decisions.
• Approves quality systems and programs for new method transfers, method validation, review/approve QC related documentation associated with a given product, review/approve method validation protocol and reports, and review/approve QC related documents for batch record disposition.
• Builds collaborative interfaces with all stakeholders to ensure quality systems such as deviation management, investigations, corrective and preventive actions and change controls are in place and followed.
• Develops meaningful quality key performance indcators(KPIs) with the QC team and participate in Quality Management Review meetings to discuss trends; Drive continuous quality improvement program for QC laboratory and partner with the QC team to implement/optimizes to improve efficiency (right the first time - analysis and documentation) and monitor/escalate as needed.
• Establishes/defines the QC self-inspections / DI programs with Compliance team; Prepare for and participate in health authority inspections and internal audits to present QA in QC quality systems.
• Drives activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; record and publish notes and action items from meetings.
• Provides support to the investigation process and follow-up to assure timely discrepancy closure; Perform final review of QC (production data as required) test data/reports to ensure conformance to the established specifications and standard operating procedures.
• Supports training program for QA for QC associates as well as QC analysts for lab specific quality systems and compliance.
• Support continuous quality improvement program for QC laboratory and partner with the QC team to implement and optimize (right the first time) and monitor/escalate as needed; Serve as SME for QA for QC to support all regulatory inspections.

• A Bachelor's degree in Life Sciences and/or related experience (Quality Control and/or Quality Assurance covering Quality Control areas) is required; Advanced degree is preferred
• Minimum of 5 years of experience in GMP Pharmaceutical Manufacturing(including laboratory operations), with at least 3 years combined relevant experience in Quality Control and/or Quality Assurance covering Quality Control areas is required
• Practical experience in supporting a Quality Control Operations Unit and operating in full compliance with global cGMP requirements is required
• Successfully handled inspections from major Health Authorities (e.g. US FDA, EMA)
• In-depth knowledge of cGMP, FDA regulations (21 CFR211, 212) and ICH regulations
• Understanding the United Stats Pharmacopoeia(USP), European Pharmacopoeia(EP), American Chemical Society(ACS)
• Proven ability to coordinate multiple projects with moderate resource requirements, risk and/or complexity