185 specialist quality control jobs found

Career Category Quality Job Description Role Description: In this vital role, you will be part of Amgen India’s (AIN) Quality Control (QC) Technical Resources team, supporting Amgen’s global Quality Control network. The QC Technical Resources team will provide centralized document management expertise across global QC functions, ensuring the efficient, compliant, and consistent management of controlled documents within Amgen’s enterprise document management system. As a QC Specialist, you will be responsible for end-to-end document lifecycle management, including document creation, authorship, review, and revision, for a range of QC processes. These include, but are not limited to, environmental monitoring/microbiology related technical assessments, laboratory consumables and equipment management, and periodic trend assessments. This position offers a unique opportunity to collaborate with QC teams across Amgen sites worldwide, contributing to process harmonization and...

Career Category Quality Job Description Role Description: In this vital role, you will be part of Amgen India’s (AIN) Quality Control (QC) Technical Resources team, supporting Amgen’s global Quality Control network. The QC Technical Resources team will provide centralized document management expertise across global QC functions, ensuring the efficient, compliant, and consistent management of controlled documents within Amgen’s enterprise document management system. As a QC Specialist, you will be responsible for end-to-end document lifecycle management, including document creation, authorship, review, and revision, for a range of QC processes. These include, but are not limited to, technical assessments and periodic monitoring reports for computer-related systems, laboratory consumables and equipment management, and periodic trend assessments. This position offers a unique opportunity to collaborate with QC teams across Amgen sites worldwide, contributing to process...

Career Category Quality Job Description Role Description: In this vital role, you will be part of Amgen India’s (AIN) Quality Control (QC) Technical Resources team, supporting Amgen’s global Quality Control network. The QC Technical Resources team will provide centralized document management expertise across global QC functions, ensuring the efficient, compliant, and consistent management of controlled documents within Amgen’s enterprise document management system. As a QC Specialist, you will be responsible for end-to-end document lifecycle management, including document creation, authorship, review, and revision, for a range of QC processes. These include, but are not limited to, general laboratory practices related to Cell Biology, Chemistry, Microbiology, Biochemistry, and Immunology, laboratory consumables and equipment management, and periodic trend assessments. This position offers a unique opportunity to collaborate with QC teams across Amgen sites worldwide,...

We are currently looking to fill a Senior Quality Compliance Specialist, Quality Assurance position on the Quality Assurance Change Control Team.   This role works within the QA Change Control Team to facilitate partner relationships and oversee operational activities regarding partner change notifications. As a Senior Quality Compliance Specialist, Quality Assurance, a typical day might include the following: • Acting as Regeneron’s representative in meetings with external Partners to discuss changes for applicable products • Participating in internal cross functional teams on global change management of partnered products • Sponsoring and advocating for Continuous Improvement activities and working with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Partner Notification Process and associated procedures • Developing relationships with end users and providing advice on best...

We are currently looking to fill a Technical Resources Specialist part of our QC Technical Resources Chemistry Team. This position is a Monday-Friday 8am-4:30pm schedule. This position will be supporting project management of validation and qualification activities, transfer to partner and contract sites, and life cycle management of assays utilized in Quality Control testing. Regeneron has successfully commercialized numerous products and in this fast-paced environment with a strong pipeline, QC Technical Resources Specialists have the opportunity to develop scientifically and also gain insight into other areas of the business. As an QC Technical Resources Specialist, a typical day might include the following Project manage validation and qualification activities within the QC TR Chemistry group Collaborate with internal and external teams to coordinate project management activities Write and revise assay transfer protocols to external partners and contract labs...

Career Category Quality Job Description Join 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 four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be...

Career Category Quality Job Description Join 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 four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part...

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. Summary:   The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to...

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. Summary:   The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to...

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. Summary:   The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to...

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. Summary:   The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to...

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. Summary:   The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to...

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere. Summary:   The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Medical, Legal, and Regulatory (MLR) Specialist supports the MLR team by working closely with the internal stakeholders, and external agencies to ensure that project goals are met through excellent coordination and communication. Administrative duties, such as preparation of meetings agendas, documentation of meeting minutes, and project-related activities may also be required.  This role will coordinate reviewers across the business to meet company timelines. This role will work with leadership across all functions (including, but not limited to, Marketing, Medical Affairs,...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Regulatory Operations Specialist I supports regulatory compliance by executing and managing operational regulatory activities across the product lifecycle. This role is responsible for enabling efficient regulatory processes through the coordination of regulatory submissions, management of regulatory data and systems, and support of ongoing registrations, licenses, and records. The Regulatory Operations Specialist works closely with Regulatory Affairs and cross‑functional partners to ensure regulatory information is accurate, traceable, and maintained in a state of inspection...

Career Category Information Systems Job Description Join 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 four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your...

Are you ready to take your career to the next level by joining a global medical device market leader in diabetes care? At Insulet Corporation, we are transforming lives with innovative products that empower people living with diabetes to take control of their health. Over years of technological advances, we developed Omnipod®, a line of tubeless, wearable, Pod-based insulin management systems.  Position Overview As a Clinical Services Manager, you’ll play a pivotal role in driving our patient-centric mission forward by creating a culture of collaboration aimed at simplifying life for people managing their diabetes.  In this role, you’ll be the clinical expert in the field, conducting training and guiding healthcare providers in integrating Insulet’s products into their patient care strategies. Your work will go beyond training—by understanding the clinical goals of providers and the unique needs of patients, you’ll create customized approaches that truly make a difference....

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Career Category Manufacturing Job Description Specialist Contract Development & Manufacturing The Specialist Contract Development & Manufacturing at Amgen provides oversight of New Product Introductions (NPI), technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards.  They provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success. In this dynamic role, you will provide a strategic dimension to Amgen's manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to our patients. Responsibilities: Project Management and Technology transfers: The role involves leading and...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...