Performs cGMP documentation/data review (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records. QMS process support for change controls and quality investigations. Performs AQL inspection of final filled product. Performs area line clearance operations in support of manufacturing operations. Provides QA oversight and performs real ti

Responsible for the following areas Networking Devices Firewalls, routers, and switches Network Administration LAN, WAN & Wireless Network Services and Protocols DHCP, DNS, TCP/IP, VPN SQL Database administration & management Microsoft Infrastructure Windows Server, Active Directory, Exchange, SharePoint Business Applications Master Control, Dynamics GP, QAD EE ERP Enterp

Help Maintain, Troubleshoot and diagnose automated control systems problems, working closely with Facilities Technicians, maintenance and Engineering personnel. Collect and review BMS alarms reviews for completeness. Ensure well documented on time completion of CMMS documentation including logbook entries, Work Orders and Alarm audits. Communicate with supply vendors to c

Maintain reliability systems and programs to improve uptime. Track and analyze historical data of operations and KPIs. Provide input for continuous improvement in the areas of Manufacturing, facilities and engineering. Provide input and author SOPs, Validation Protocols, Deviations, CAPAs and other GMP documentation. Document changes to systems per change management proce

Oversees F&E activities in real time (QAOTF) to ensure compliance with internal procedures and global regulatory requirements are met. Provide equipment, system, and facility validation /qualification guidance and ongoing support for established / validated processes Leading cross functional activities, in providing approach, methodology and deliverables. Partnering with

Documentation Preparation to include but not limited to the following o Authoring of User Requirements and Functional Specifications o Authoring of cover protocols for vendor supplied Installation, Operational and Performance protocols o Authoring of Validation Summary reports Performing 21 CFR Part 11 Risk Assessments Maintaining an inventory of GMP Computerized Systems

Perform sanitization duties in the cleanroom while aseptically gowned. Accurately record and complete documentation as required, including logbooks and forms in compliance with SOP guidelines. Remove and collect all used disinfectant solution waste and place in the appropriate disposal unit. Administrative tasks including attendance of regularly scheduled departmental mee

Drives performance and continuous improvement, while managing diligent execution of day to day performance. Manages all quality control microbiology activities including hiring, training, and developing QC micro personnel. Establishes and communicates high performance standards, defines clear accountability, and leads by adopting improvement strategies to reduce operation