Sr. QA Specialist, Operations

1.     Perform various quality assurance checks during all manufacturing processes;

2.     Assess regulatory and quality risks in manufacturing activities and processes according to regulatory agency rules and guidelines;

3.     Conduct quality audits of manufacturing processes and finished products;

4.     Investigate and resolve quality issues and determine any deviations from established procedures;

5.     Monitor and analyze quality data to identify trends and opportunities for improvement;

6.     Maintain and update quality documentation and records;

7.     Provide oversight of production activities including monitoring use of complex equipment;

8.     Assist with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA and international guidelines;

9.     Analyze and identify root causes for production and quality control issues and implement corrective actions; and

10. Monitor all equipment used for manufacturing to assure quality of final products.

Requires a Bachelor’s degree in Drug Regulatory Affairs and 4 years of experience in job offered or 4 years of experience in Related Occupation as a Senior Quality Assurance Specialist or any other job title performing the following job duties:

1. Assess regulatory and quality risks in manufacturing activities and processes according to regulatory agency rules and guidelines;
2. Investigate and resolve quality issues and determine any deviations from established procedures;
3. Monitor and analyze quality data to identify trends and opportunities for improvement;
4. Maintain and update quality documentation and records;
5. Assist with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA and international guidelines; and
6. Analyze and identify root causes for production and quality control issues and implement corrective actions.

 Salary: $91,478.00/year.  Apply online at https://www.catalent.com/ under Posting Number 0090356.