Senior Specialist, Quality Assurance

General Description: 

This position is based in Hopewell, NJ.  Supports QA manufacturing activities with strong focus in QC Microbiology. Support for Biochemistry and the analytical chemistry department may also be required.  Candidate will ensure the successful day-to-day management of reviewing and approving GMP paperwork including logbooks, analytical raw data, Environmental Monitoring reports, and other ancillary documentation that support GMP Manufacturing.  Candidate will also provide QA oversight of OOS and deviations pertaining to samples from Production, Environmental Monitoring and WFI systems.  Will be responsible for leading GEMBA walks on a routine basis to ensure day-to-day compliance and to ensure the laboratory and facility are always inspection ready.  

Works to support QA objectives whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs needed to support the business. Conducts internal GMP inspections and will support Health Authority audits. 

Essential Functions of the Job:  

• Implementing and monitoring all Quality Assurance activities in QC Microbiological laboratories and facility/utility space to ensure compliance with FDA/EU regulations, covering cGMP for commercial medicinal products and clinical material for human use.   

• Ensuring the QA Compliance of departmental SOPs (writing & revising), ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially. 

• Knowledgeable in cGMPs: 21 CFR Parts 11, 210, 211, and 600, EU Annex 1. 

• Demonstrated expertise with ERP systems and lab data acquisition systems such as: Empower, Maximo, Veeva, LIMS, MODA, and SAP. 

• Ensuring all activities are performed in accordance with GMPs, SOPs and Health and Safety policies. 

• Awareness of USP/EP, ICH Guidelines, Annex 1, and QC methodology updates to ensure compliance with current testing and specifications. 

• Ensuring appropriate escalation and follow up for non-conformities within Laboratories and Utility areas and issuing deviations when appropriate. 

• Ensuring that the Quality department meets or improves key performance indicators (KPIs). 

• Undertaking any other duties for any department within the business, which may be requested by QA Management, for which training and/or an explanation has been provided and understood. 

• Perform other duties as assigned 

Supervisory Responsibilities:   

• None 

Computer Skills: 

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint, MS Project). 

Required Education/Experience:

• Experience with writing/reviewing deviations, Environmental Monitoring data/trends, aseptic technique, technical writing, clean room gowning  

• Must have worked previously in the Biotechnology area of pharmaceuticals.  

Travel: 10% Travel may be required.