Senior Quality Assurance Associate, Compliance and Vendor Management

4 weeks ago

Chantilly, Virginia, United States Granules Pharmaceuticals Full time
Job Summary

The Senior Quality Assurance Associate, Compliance and Vendor Management position is responsible for ensuring compliance with cGMP and internal policies, procedures, and specifications. This includes managing the vendor qualification program in accordance with cGMP and related company SOP's, state, federal and local laws as applicable.

Key Responsibilities
  • Author and review standard operating procedures.
  • Completion and organization of vendor qualification documentation.
  • Ability to redesign the vendor management program.
  • Knowledge and the ability to perform audits of contract testing labs, contract packagers, contract manufacturers, and raw material vendors when needed.
  • Knowledge in the serialization of pharmaceutical products.
  • Ability to write change controls for changes made to processes or vendors.
  • Ability to write investigations using root cause analysis tools.
  • Ability to write quality agreements.
Requirements
  • Knowledge of Quality Management Systems, including FDA compliance standards, cGMP regulations/guidelines.
  • Knowledge of USFDA regulations/guidance's and ICH guidance's.
  • Knowledge of Change Control/Deviation management and CAPA identification/implementation.
  • Proficient in Microsoft Word, Excel, Power Point.
  • Ability to analyze data/information and to assess and resolve complex issues, as required.
  • Ability to work and communicate with cross-functional teams.
  • Ability to manage multiple priorities and re-prioritize tasks, as required.
  • Flexible and able to adapt to company growth and evolving responsibilities.
  • Strong attention to detail and excellent organization.
  • Excellent oral and written communication skills.
  • Experience in writing various quality agreements.
Education and Experience
  • Bachelor's degree in a Natural Sciences (i.e., Biology, Chemistry), Pharmacy, or Engineering.
  • Minimum (5) five years' experience in a Quality role managing a vendor qualification program.
  • Minimum (2) two years' experience in performing audits.
  • Not required but desired an auditing certification such as ASQ.

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