Manager, Quality Assurance - GxP (GCP Auditing) Remote
Axsome Therapeutics Inc- Full Time
- Junior (1 to 2 years)
Candidates should possess a Bachelor's degree in a related field, and a minimum of 2 years of experience in CAPA work within a regulated manufacturing environment. They are expected to have experience with route and non-routine manufacturing issues, as well as familiarity with cGMP guidelines.
The Associate CAPA Specialist will generate exception/CAPA documentation, including non-conformance and investigation reports, independently investigate all aspects of exception events to determine root causes and recommend corrective and preventive actions. They will coordinate meetings, communicate cross-functionally, manage multiple CAPA projects, track and trend CAPA information, and contribute to identifying and implementing process improvements, while ensuring compliance to cGMP and documenting all activities accurately.
Healthcare solutions in diagnostics and devices
Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.