Senior Associate QA - West Greenwich, RI

, ATTENTION MILITARY AFFILIATED JOB SEEKERS, - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to, Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is 'On-Site' at the location detailed in the job post.At Amgen, if you feel like youâre part of something bigger, itâs because you are. Our shared missionâ”to serve patients living with serious illnessesâ”drives all that we do.Since 1980, weâve helped pioneer the world of biotech in our fight against the worldâs toughest diseases. With our focus on four therapeutic areas â“Oncology, Inflammation, General Medicine, and Rare Diseaseⓠwe reach millions of patients each year. As a member of the Amgen team, youâll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youâll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Senior Associate QA IWhat you will doLetâs do this. Letâs change the world. In this vital role you will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff, and also to provide coaching, guidance and direction to Manufacturing, Quality Control, and Facilities/Engineering staff regarding compliance and quality systems.This position works a rotating day shift, with five days worked for one week (ex: M, Tu, F, Sa, Su) and two days the following week (W, Th). Shift hours are 7am to 7pm.Provide Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.Provide Quality oversight during on-the-floor analytical testing.Ensure that facilities, equipment, materials, processes, and procedures follow cGMPs and other applicable regulations.Ensure that changes that could potentially impact product quality are assessed according to procedures.Ensure that deviations from established procedures are investigated and documented per procedures.Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.Perform review and approval of cGMP processes, procedures, and records, including but not limited to, Standard Operating Procedures (SOPs), batch records, deviations, and logbooks.Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports.Alert senior management of potential quality, compliance, supply, or safety plete assigned training to permit execution of required tasks.Drive operational improvement initiatives, programs, and projects.Perform other tasks, as assigned, to assist in completion of activities associated with meeting group, departmental, and company goals.

Created: 2025-10-04