Current jobs related to Senior Associate Quality Control, Sample Management and Stability - Holly Springs - Amgen
-
Senior Associate Quality Assurance
3 weeks 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 leading...
-
Senior Associate Quality Assurance
3 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...
-
Senior Associate Quality Assurance
3 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...
-
Holly Springs, United States Amgen Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance professional to join our team at Amgen's North Carolina site. As a Senior Associate Quality Assurance, you will play a critical role in ensuring the quality of raw materials received at our site, supporting the inspection, sampling, and testing of these materials.Key ResponsibilitiesInspect...
-
Senior Specialist, Quality Control
1 month 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...
-
Holly Springs, United States BioSpace, Inc. Full timeJob DetailsDefy Imagination with a Career in Quality AssuranceAre you a detail-oriented professional looking to take your career to the next level? Do you have a passion for ensuring the highest quality standards in a fast-paced environment? We're seeking a Senior Associate Quality Assurance professional to join our team at BioSpace, Inc.Key...
-
Sr Associate QA
2 months 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...
-
Senior Director of Quality Control
6 days ago
Holly Springs, North Carolina, United States Fujifilm Full timeOverviewFujifilm is seeking a highly skilled and experienced Senior Director of Quality Control to lead our Quality Control Laboratories at our state-of-the-art facility in Holly Springs, North Carolina. As a key member of our site leadership team, you will be responsible for implementing GMP industry standard methodologies and ensuring the sustained and...
-
Holly Springs, NC , USA, United States Amgen Full timeAbout the RoleWe are seeking a highly skilled and motivated Senior Associate Quality Assurance professional to join our team at Amgen's North Carolina site. As a key member of our Quality Assurance team, you will play a critical role in ensuring the quality and integrity of our raw materials and products.Key ResponsibilitiesInspect and sample raw materials...
-
Microbiology Quality Control Specialist
3 weeks ago
Holly Springs, North Carolina, United States Eurofins USA PSS Insourcing Solutions Full timeJob OverviewThe Microbiology Quality Control Specialist plays a crucial role in the operational functions of the Quality Control Microbiology laboratory. This position is tasked with conducting microbial assessments on various samples, including in-process drug substances, drug products, environmental monitoring (EM), utilities monitoring (UM), and raw...
-
Specialist Quality Control
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...
-
Holly Springs, NC , USA, United States BioSpace, Inc. Full timeJob DetailsDefy Imagination with a Career in Quality AssuranceAre you a detail-oriented professional looking to take your career to the next level? Do you have a passion for ensuring the highest quality standards in a fast-paced environment? We are seeking a Senior Associate Quality Assurance professional to join our team at BioSpace, Inc.Key...
-
Senior Manager Project Controls
17 hours ago
Holly Springs, United States Amgen Full timeJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on...
-
Lead Microbiological Quality Control Scientist
3 weeks ago
Holly Springs, North Carolina, United States Eurofins USA PSS Insourcing Solutions Full timePosition OverviewThe Lead Microbiological Quality Control Scientist plays a pivotal role in overseeing the essential operational functions of the Quality Control Microbiology laboratory within our organization. This role involves executing and providing training on microbial testing for all in-process drug substances, drug products, environmental monitoring,...
-
Virology Quality Control Scientist II
3 weeks ago
Holly Springs, Georgia, United States Fujifilm Corporation Full timeOverview Join a Leading Life Science Manufacturing Organization At Fujifilm Corporation, we are committed to advancing healthcare through innovative biopharmaceutical manufacturing. We are expanding our operations and seeking dedicated professionals who are passionate about making a significant impact in the field of life sciences. About the Role The...
-
Senior Analytical Chemist
2 weeks ago
Holly Springs, United States FUJIFILM Corporation Full timeAbout the RoleThe Senior Analytical Chemist works with limited direction to execute QC analytical chemistry methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Senior Analytical Chemist...
-
Supervisor, Quality Control Microbiology
1 week ago
Holly Springs, North Carolina, United States Fujifilm Full timeAbout the RoleThe Supervisor, QC Microbiology is a key member of our Quality Control team, responsible for providing day-to-day supervision and ensuring audit readiness in the laboratory.Key ResponsibilitiesProvides day-to-day supervision and scheduling of the QC Microbiology laboratory team.Applies expertise in laboratory methodology and compendial...
-
Pest Control Technician Expert
3 weeks ago
Holly Springs, United States Triangle Pest Control Full timeJob OverviewWhy consider a career with Triangle Pest Control?At Triangle Pest Control, we embody the principle of professionalism in service. Our work environment is built on the foundation of respect, integrity, and excellence. We are committed to keeping our promises, enhancing quality of life, and providing peace of mind in every interaction. As a locally...
-
Estimating Senior Manager, Project Controls
2 months 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...
-
Estimating Senior Manager, Project Controls
4 months 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...
Senior Associate Quality Control, Sample Management and Stability
4 months ago
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 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 Control, Sample Management and Stability
Live
What you will do
Lets do this. Lets change the world. In this vital role you will be responsible for supporting the Quality Control Laboratory start up as a member of the QC Support Team. Responsibilities will include Sample management and Stability lab setup, validation of laboratory electronic systems and equipment, writing procedures and reports and ownership of QC Quality Records (Change controls, Deviations/CAPAs). Role may involve travel to support method or knowledge transfers. The Senior Associate QC Support will initially report to the Director of Quality Control. This individual will provide technical leadership in the QC Sample Management and Stability Laboratory. This role will support site start up and then transition to support manufacturing operations, and as such some extended hours, shift and weekend work may be vital.
Under minimal direction, the successful candidate will support the startup of the QC organization by:
- Lead the QC Support team by developing/maintaining processes and procedures for sample handling and storage.
- Assist in the development cGMP system for incoming and outgoing samples.
- Assist in the development of cGMP system for stability samples. Preparing protocols and defining the process by which to stage/load samples and handle pulls.
- Develop/oversee monitoring system for sample and stability storage units.
- Own and handle Deviation, CAPA and Change Control records to support Quality Control.
- Work collaboratively with site teams to establish work order and PM system for laboratory equipment.
- Review validation documents to support equipment and computerized system onboarding for sample management lab.
- Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, technical assessments, microorganism assessments.
- Assist with procurement activities for consumables and critical reagents for lab start up.
- Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
- Support routine activities over the weekends and public holidays as required.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The quality control professional we seek is a effective leader with these qualifications.
Basic Qualifications:
- High school/GED + 4 years of Quality experience OR
Preferred Qualifications:
Degree in a related scientific field such as Chemistry, Biochemistry, Physics or Chemical Engineering.4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.Proficient in the use of LIMS & LMES/CIMS.Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.Strong written and verbal communication skills including technical writing and presentation.Experience with equipment and method validation, verification, and transfer including the change control process.Interact effectively with variety of communication and working styles and ability to work well in teams.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
