Quality Assurance Compliance Specialist II

About this opportunity :

The Quality Assurance Compliance Specialist is responsible to supporting the site’s regulatory intelligence compliance and auditing functions. This position provides regulatory compliance management within the Quality organization.  

Key Responsibilities:  

• Support inspection administration during Health Authority and client inspections. 
• Support Avecia’s Health Authority and client audits to identify potential risks, including approval of any final reports and completion of identified CAPAs. 
• Provide administrative and operational support within the Quality Assurance Department, including the retrieval, organization, and management of quality documents, records, and data to support and ad hoc documentation requests. 
• Participate in the preparation or review of responses to Health authority and client inspectional observations.  
• Support the execution of commitments identified during Health Authority and client audits and ensure that CAPAs are closely monitored and completed in a timely fashion.  
• Support the compilation of Nitto Avecia’s KPI metric requirements and Management Review process by compiling, and trending quality data related to audit findings. 
• Maintain Site Master File and issue Letters of Authorization
• Support Internal Audit Program: Perform and/or support Nitto Avecia internal audits to identify potential risks, including approval of any final reports and CAPAs, as needed. 

Required Skills/Abilities: 

• At least 5 years’ experience in a regulated/GMP industry required, with experience in Pharmaceuticals or Biotechnology preferred. 
• This position requires a candidate with regulatory inspection experience to lead Nitto Avecia’s inspection readiness program. 
• Comprehensive working knowledge of cGMP’s/FDA regulations, Quality systems, FDA Guidance documents, USP, ICH and other applicable laws and their interpretation, implementation 
• Proficient with PC-based word processors and spreadsheets.  
• Proficient with electronic quality management systems  
• Intermediate understanding of ICH, ISO, cGMP, USP, EU, and other relevant regulatory guidance/requirements. Specific knowledge of 21 CFR 210, 21 CFR 211, ICH Q7, ICH Q9, ICH Q10, Eudralex – Volume 4, is desired. 
• Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight. 
• Problem-solving skills with the ability to adapt to changing priorities and timelines. 
• Strong leadership and communication skills, including establishment of clear expectations and development of metrics and KQIs to monitor performance and ongoing activities. 
• Demonstrated ability to write effectively, present ideas publicly, and proactively share knowledge with others to encourage team development.  
• Ability to build positive working partnerships with other department management teams to successfully support validation and commissioning timelines. 
• Experienced with making decisions through critical reasoning to solve standard and involved problems that may impact multiple departments. 
• Experienced in the use of electronic systems such as eQMS 
• Prior experience with clinical and commercial manufacturing is preferred. 
• Requires the ability to gown into clean rooms and wear PPE. 

The annualized salary range for this position is between $71,500.00 and $87,500.00.