QA Associate (Hybrid Role)
We invite motivational professionals in the life science industry to join an innovative International Pharmaceutical company located in New York. Within this unique job opportunity, you will be accountable for carrying out the Quality Assurance (QA) department's daily operational tasks for In-Market Quality. The tasks assigned to this position are meant to ensure the marketed products comply with relevant regulatory requirements and internal compliance. This role will allow you to develop and work with a forward-thinking group of experts in a positive work environment. Are you ready to be apart of a team who believes in its company's products and only comes into the office 3 days a week while working remote the other 2? If yes, this role is meant for you!
- Responsible for ensure that the companies marketed products comply with relevant regulatory requirements and internal compliance. Every task must be completed in compliance with GMP guidelines.
- Full-Batch release program execution.
- Initiate and manage deviations and CAPA's to completion.
- Responsible for conducting quarterly product complaints to management and investigate as necessary to improve the experience for customers and the quality of the products.
- Will need to ensure audits are done in a timely basis and in alignment with the company's procedures of Fulfillment and Rework Centers.
- Maintain SOP Document Management.
- Will need to compile date of Quality Systems for Quality Management Review.
- Approve Annual Product Reviews to confirm process consistency, evaluate trends, and decide whether to make changes to specifications, manufacturing, production, or control methods.
- Complete additional tasks as given and providing overtime when necessary.
- B.S. in Chemistry or other Life Science field.
- Minimum of 5 years in either Quality Assurance or Quality Control in the Pharmaceutical or Life Science Industry.
- Excellent knowledge of FDA guidelines.
- Leadership skills.
- Experience in Quality Electronic Systems: Trackwise and SAP are a bonus and an asset.
- Hybrid Role: 3 days in office, 2 days Remote
- Full Benefits Package: Medical, Dental, 401k, etc.