Quality Assurance Specialist

The QA Specialist will report to the Quality Assurance Manager within the Quality Department of the Angelini Albany ThermaCare production facility.

Areas of responsibility :

Complaints, as required :

• Complete complaint investigation reports following the governing site procedures
• Responsible for processing and closing complaints in a timely manner.
• Approves complaint reports per the site procedure as a responsibility delegated by Person Responsible for Regulatory Compliance (PRRC Article 15 of the EU MDR, 2017 / 45).
• Generates Complaint metrics for the complaints systems per the site procedure.
• Work with the QA manager to resolve issues associated with complaints or the complaint system.
• Will act as the site SME for the complaint process.
• Responsible for updating complaint SOPs as required.
• Initiates incidents in the investigation system per site procedures as required, i.e. if the complaint has a manufacturing root cause.
• Attends complaint meetings as schedule by the Global Complaints group.
• Reconciles Medical Device Reports data with the complaint investigations

CAPA / Investigations, as required :

• Participates in the CAPA Review Board
• Approves CAPAs
• Provides Manufacturing Investigation Report data to Pharmacovigilance as needed

SAP BOM and Artwork Approval, as required :

• Update and approve BOM and Artwork changes, as necessary
• Work with supply chain to ensure change controls for BOM and Artwork changes are document correctly

DHR Review / Release, as required :

Review completed DHRs and process release within required timeframe

Support internal and external audits, as required.

QUALIFICATIONS AND EXPERIENCE

• 2+ years of experience in a GMP regulated environment, required.
• 3+ years of experience in regulatory affairs or in quality management systems relating to medical devices, preferred.
• B. Sc. degree in life science, engineering or other related degree, preferred
• Knowledge of medical devices regulations and ISO Standards i.e., 21CFR Part 820, EU MDR and ISO13485 : 2016.
• SAP and TrackWise knowledge a plus.
• Professional communication skills, written and oral, with excellent computer skills including Word, Power Point and Excel, at a minimum.
• Ability to work effectively in a team environment and communicate with team members and colleagues at all levels of the organization.n
• Strength in prioritizing and handling several projects concurrently and meeting strict deadlines
• Open minded and flexible, able to understand other cultures, professional maturity
• Potential to handle larger responsibilities.
• The ability to lead efforts aimed at the identification of problematic situations, reporting issues, and the development of resolutions and decision making is required.

Angelini Pharma is an equal Opportunity Employer .

We believe that diversity is a huge value that contributes to individual and company success.

We are committed to create a diverse and inclusive environment.