QA Associate

Job Responsibilities:

• Administer the site's change control process, managing the electronic change control system, and overseeing the change review board.

• Provide support for various quality system processes, including managing change deviation/CAPA, document control, and validations.

• Play a crucial role in supporting projects aimed at enhancing change control processes at the facility.

• Monitor activities and prepare metrics related to your responsibilities with a commitment to escalating issues appropriately.

• Responsible for collaboration with cross-functional personnel will be encouraged to continuously improve the Quality System.

• Support the development and execution of training programs for employees on quality assurance practices.

• Document current state, risks, and process improvement goals

• Ensure compliance with cGMP, Company SOPs and FDA requirements during all phase of operations

• Perform process checks and verification's to ensure the quality is maintained

• Stay informed about industry regulations and best practices to ensure ongoing compliance.

Qualifications:

• Bachelor's degree in a relevant scientific or engineering field.
• 2+ years experience in QA pharmaceutical or radiopharmaceutical industry.
• Strong knowledge of regulatory requirements, including FDA and cGMP.
• Excellent attention to detail 
• Effective communication and interpersonal skills.