Quality Assurance Compliance Specialist II

Nitto Denko Corp. • Milford, MA

16h • $71,500 - $87,500 • Onsite

About The Position

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

Requirements

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed