Senior Associate Quality Assurance
2 weeks ago
HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Associate Quality Assurance Live What you will do Let’s do this. Let’s change the world. In this vital role you will be a part of our Amgen North Carolina Quality Assurance team. The role will support the inspection, sampling, and to perform Raman Spectroscopy testing of raw materials that are received at the Amgen North Carolina site. This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process. This role will also demonstrate leadership skills in support of scheduling, coordination, and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training. Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met Perform sampling from containers of medias and other chemicals to facilitate the testing of samples Use RAMAN technology with TruScan equipment to identify chemicals Ensure that inspection & sampling results are complete and detailed according to written procedures and cGMP requirements Responsible for accurately detailing inspection, sample, and test results in Amgen’s systems Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures Ability to determine the color and appearance of components match required attributes Leads/Participates in inspections/walkthroughs to ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP regulations and other safety standards. Oversee the warehouse's quality assurance, which encompasses managing quality documentation such as deviations/CAPAs, change controls, and work orders, ensuring compliance with procedural standards, and verifying that evaluations and assessments of various partners are detailed and precise. Support inspection readiness activities including site audits and inspections Maintains project plan commitments supporting critical projects Leads and Supports Continual Improvement initiatives, programs and projects Serve as a shift lead in the raw material inspection and sampling areas Assist area management with the prioritization and scheduling of tasks Serve as a trainer and subject matter expert in tasks associated with raw material inspections, samples, and testing Author, own, review and approve controlled documents for the area including SOPs and FORMs Initiate, and own deviation records and CAPAs associated with events and projects in ANC’s raw material inspections, samples and testing areas Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The quality assurance professional we seek is a leader with these qualifications. Basic Qualifications: High school diploma / GED and 4 years of cGMP inspecting and/or sampling experience OR Associate’s degree + 2 years of cGMP inspecting and/or sampling experience OR Bachelor’s degree + 6 months of cGMP inspecting and/or sampling experience OR Master's Degree Preferred Qualifications: Strong understanding of cGMP regulations and GDP requirements SAP, LIMs, and TrackWise experience Experience with RAMAN technology Experience as a Trainer in raw material inspections, sampling, and testing Ability to lift and perform physical activities with raw materials Strong written and verbal communication skills Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com
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Senior Associate Quality Assurance
2 weeks ago
Holly Springs, United States Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading...
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Senior Associate Quality Assurance
2 weeks ago
Holly Springs, United States BioSpace, Inc. Full timeJob Details HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading...
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Quality Assurance Specialist
1 month ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
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Quality Assurance Specialist
1 month ago
Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
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Quality Assurance Associate
3 days ago
Holly Springs, United States Food Lion Full timeJob SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Associate to join our Retail Operations team at Food Lion. As a Quality Assurance Associate, you will play a critical role in ensuring that our stores maintain the highest standards of quality and cleanliness.Key ResponsibilitiesMaintain a clean and safe shopping environment...
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Senior Quality Assurance Engineer
1 week ago
Holly Springs, United States FUJIFILM Corporation Full timePosition OverviewExplore an opportunity at a leading Life Science Manufacturing Facility & CDMOThe contributions we make at FUJIFILM Corporation are crucial, and we are in search of skilled professionals to enhance our team. Our expansion includes new locations, enhanced capabilities, and a commitment to fostering a passionate workforce dedicated to making a...
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Senior Quality Assurance Engineer
1 week ago
Holly Springs, United States FUJIFILM Corporation Full timePosition OverviewEmbark on a career with a leader in Life Science Manufacturing and Contract Development and Manufacturing Organization (CDMO)The role at FUJIFILM Corporation is crucial in ensuring the quality and compliance of our biopharmaceutical manufacturing processes. We are expanding our capabilities and seeking dedicated professionals who are...
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Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
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Senior Quality Assurance Engineer
2 weeks ago
Holly Springs, United States FUJIFILM Corporation Full timePosition OverviewEmbrace Your Passion at FUJIFILM CorporationThe role we offer is crucial in the realm of biopharmaceutical manufacturing, and we are in search of skilled professionals to enhance our team. As we expand our facilities and capabilities, we invite dedicated individuals who are committed to making a significant impact in the industry.About the...
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Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...
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Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
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Holly Springs, Georgia, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
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Holly Springs, North Carolina, United States Fujifilm Full timeAbout This RoleThe Quality Assurance Senior Engineer, DSM Disposition, is a critical position responsible for establishing and maintaining a robust and efficient disposition program at our manufacturing site.This role ensures the quality and compliance of product disposition and identifies opportunities for continuous improvement. The successful candidate...
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Sr Associate QA
1 month ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
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Senior Specialist Quality Compliance
3 weeks ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
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IT Quality Assurance Lead
5 days ago
Holly Springs, United States FUJIFILM Corporation Full timeAbout This RoleThe Senior IT Engineer 2, CSV Specialist is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation (CSV). This role provides input and determines action items on all GxP Manufacturing and IT Computerized Systems, as well as prepares validation documentation, maintains a validated state, with a focus on...
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Quality Assurance Specialist
2 weeks ago
Holly Springs, United States Rishabh RPO Full timePosition OverviewJob Title: Quality Assurance Specialist - VirologyAssignment Duration: 12 monthsWork Schedule: Monday - Friday (standard business hours)Work Environment: OnsiteImportant Note: This position requires a current flu vaccination.Key ResponsibilitiesThe primary focus of this role involves executing tasks related to method validations and...
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Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
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Sr Associate QA
1 month ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...
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Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...
