As a member of our QA team, this role is responsible for Quality Assurance Compliance activities such as document management for investigations, CAPA, SOPs, qualification and validation reports, and QC data. Supporting organizational and operational excellence initiatives and support of internal and external audits with clients and regulatory orgs.

• Provide guidance through all stages of the investigation and/or CAPA processes.
• Develop investigation strategies
• Gather and maintain all required information maintain investigation and CAPA log
• Review and approve investigations and CAPAs
• Conduct weekly update meetings stakeholders.
• Monitor KPIs provide reviews and updatesto management
• Communicate and promote the importance and value of regulatory compliance and internal best practices
• Track compliance related metrics such as deviations and CAPAs
• Support internal and/or client audits if necessary

Required Experience and Knowledge

• Minimum 7 years’ experience in QA in the life sciences
• Familiarity and experience creating and reviewing all cGMP/cGTP related documents
• Understanding of electronic quality system applications for training, deviations, CAPA management, etc.
• Familiar with FDA, ISO, and other regulatory guidelines.
• In-depth understanding GMP, GDP GLP practices.

Preferred Experience and Knowledge

• Technical understanding of aseptic manufacturing of biologics preferred.
• Clinical and commercial manufacturing
• Experience supporting health authority inspections and/or client audits preferred.

We are a people-centric company and strive to provide rewarding careers with consistent growth potential to all of our talented people. 

For fastest response and priority consideration, apply through Oak Grove Search via this website or at https://oakgrovesearch.com