Sr. Quality Assurance Associate, Compliance

3 weeks ago

Chantilly, United States Granules Full time
Job DescriptionJob DescriptionDescription:

Job Summary
The Sr. Quality Assurance Associate, Compliance & Vendor Management position ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for the vendor qualification program in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations ICH guidelines on how to run a vendor management program. The persons are fully responsible for the execution and oversight of the vendor management program for all vendors and service providers of Granules Pharmaceuticals.

Principle Accountabilities

JOB DESCRIPTION & 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 but not limited to contract testing labs, contract packagers, contract manufacturers, and raw material vendors when needed.
  • Knowledge in the serialization of pharmaceutical products.
  • Any other activity as assigned by the Supervisor
  • 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.
  • Any other activities as requested by management.

Reports to

Quality Assurance, Director

Internal/External Contacts
N/A


Requirements:

Knowledge & Skills

  • 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.

Minimum Experience & Education

  • 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.


Physical Requirements/Working Environment

  • While performing the duties of this job, the employee is regularly required to, stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard.
  • Light to moderate lifting up to 10-15 lbs. is required.

Travel Up to 25 % travel may be necessary.


Disclaimer The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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