's degree in Engineering, LifeSciences, or related field;advanced degree preferred. Minimum of 5 years of experience in CQV...
Responsibilities: Independently perform routine drug metabolism assays and generate high quality data, noting significant deviations to be elevated to senior staff. Collaborate with department team members including Bioanalytical counter...
Roles & Responsibilities: Bachelor's degree in engineering required. 2-4 years' experience required. Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliab...
Roles & Responsibilities Product Ship Holds & Communication Non-Conformance events including root cause investigations CAPA ownership Determines and executes the product/part quality inspection Methods and tools. Transfer Integrations Re...
Responsibilities: Provide quality assurance oversight for C&Q, verification, and validation activities, ensuring compliance with GMP, FDA, and other regulatory requirements. Collaborate with engineering, operations, and IT teams to ensur...
Responsibilities: Play a pivotal role in leading statistical programming activities for multiple clinical trials, ensuring the timely and accurate delivery of analysis datasets, tables, listings, and figures. Collaborate closely with cro...
Responsibilities: Prioritize timely completion and remediation of Corrective Action and Preventive Action (CAPA) - performing investigations, corrections, corrective actions, preventive actions and effectiveness checks. Perform review an...
Roles and Responsibilities: 4+years' experience in a medical device manufacturing environment. Strong preference for assembly automation systems experience. Validation experience: IQ, OQ, PQ and TMVs Automation control systems ba...
, and cross-functional collaboration within the lifesciences industry. Regulatory Strategy and Submissions. Develop and execute... in regulatory affairs within the lifesciences industry, with a focus on clinical regulatory filings. Proven track record...
Responsibilities: Support the initiatives of the Quality Assurance department Supply chain support in the development and maintenance of a supplier rating system and supplier evaluation Develop and provide statistical analysis of qualit...