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Sr. Quality Assurance Associate, Compliance & Vendor Management - Chantilly Virginia
Company: Granules Pharmaceuticals Location: Chantilly, Virginia
Posted On: 04/26/2024
Job Type Full-time Description 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
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