Quality Assurance Specialist

3 weeks ago

Dunkirk, New York, United States Pharmaceutics International Inc Full time
Job Summary:

The Pharmaceutics International Inc is seeking a highly skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for supporting a Supplier Quality system in compliance with 21 CFR part 210 / 211 regulations.

About the Role:

This position reports to the Director of Supplier Quality and involves supporting the onboarding of new suppliers/materials and maintenance tasks to ensure continued compliance to Pii's Supplier Quality Management program.

Key Responsibilities:
  • Processing and tracking supplier/material onboarding requests.
  • Attaining all necessary documentation/agreements required to qualify suppliers/materials.
  • Determining proper supplier classification from the information provided.
  • Processing and tracking Supplier Notifications of Change (SNCs).
  • Holding meetings with SMEs to evaluate the impact of supplier changes.
  • Initiating and processing Change Controls as required.
  • Generating material receipt reports and Quality Event reports to evaluate supplier performance.
  • Performing ongoing supplier evaluations.
  • Issuing Supplier CAPA requests, and follow-up to closure as required.
  • Coordinating, preparing for, and assisting with Supplier Audits.
  • Creating/editing Supplier Quality SOPs, Forms, etc. in Master Control as required.
  • Proactively identifying process improvements and communicating to Director.
  • Performing general office administrative tasks (scanning, copying, sorting, filing, etc).
  • Assistance with implementing an electronic Supplier Quality Management system (ex: Master Control).
  • Creation of Purchasing/Material Specifications as required.

Requirements:
  • BA/BS, in scientific discipline with at least two years working in the Biotech or Pharmaceutical industry under GMP conditions, preferably in Quality Assurance.
  • Effective English oral and written communication skills.
  • Proficient in MS office computer applications: Outlook, Word, Excel, etc.
  • Must be able to work independently, as well within a team and be able to assist during projects and audits
  • Must be able to gather the appropriate data to make informed decisions, as well as form teams when collective discussions are applicable.
  • Must be able to work in a fast-paced work environment which involves the ability to quickly change priorities and multi-task while maintaining a professional demeanor.
  • Travel may be required - possibly up to 10%.

Salary: The estimated salary for this role is $65,000 - $90,000 per annum, depending on experience.

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