What are the responsibilities and job description for the Quality Assurance Compliance Specialist II position at Nitto?
Avecia: Milford, MA, Massachusetts, US
Regular Full TimeAbout 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.
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