296 specialist quality assurance jobs found

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....

We are currently looking to fill multiple Quality Assurance Specialist positions. This position performs and leads activities “on the floor” in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. Available Work Schedules: Wednesday-Saturday - 1st shift Wednesday-Saturday - 2nd shift Wednesday-Saturday - 3rd shift Sunday-Wednesday - 3rd shift In this role, a typical day might include the following: Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication Train and/or mentor employees, including...

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...

Career Category Operations 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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...

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.       JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to...

Career Category Quality Job Description Specialist – QA Technical Support NPI Live    What you will do    Let’s do this. Let’s change the world.  Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.  The Quality Assurance Technical Support Specialist NPI (New Product Introduction) is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of...

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 Quality Control (QC) Technical Specialist provides services of technical nature within the quality control and clinical laboratory service areas.  This position is primarily responsible for assisting the Supervisor, Clinical Laboratory QC in scheduling, coordinating, analyzing, and implementing quality control activities in the laboratory. The QC Technical Specialist is the primary individual responsible for collecting and analyzing quality control data, and is the front line for detecting systemic test system issues for the laboratory area. The QC Technical Specialist works directly...

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....

Overview The Clinical Specialist provides clinical support for extensive medical device product lines through direct physician interaction, medical staff education and procedural consultation.   The Peripheral Intervention division of Cook Medical focuses on device technology that addresses broad cardiovascular applications, including treatment of peripheral arterial disease and pulmonary embolism prevention.   Product line includes standard and specialty wire guides, angiographic and therapeutic catheters, introducers, angioplasty balloons, balloon expandable and self-expanding peripheral stents, drug-eluting peripheral stents, and vena cava filters.   For more information about Cook Medical, visit www.cookmedical.com   Responsibilities • Provide clinical support during procedures • Identify, establish, support and develop relationships with key   clinical and non-clinical decision-makers to clinically support company...

Product Sales Specialist- Orthopaedics based in Thailand Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.   Achievement of territorial sales budget, profit and market share in line or exceeding company’s objectives through execution of approved Sales and Marketing Plans and effective control of assigned territories. What will you be doing? Meets or exceeds established annual sales quota. Initiates sales process by prospecting, scheduling of appointments, conduct sales presentations, understanding business needs, develop proposals and sales closure. Expands sales in existing accounts by introducing additional solutions and services and /or develop new and innovative applications. Closes sales by establishing rapport with potential customers, expounding on the benefits of business unit solutions and service capabilities; overcoming objection, etc. Proactively keeping up to date on product knowledge...

Overview The Clinical Specialist provides clinical support for extensive medical device product lines through direct physician interaction, medical staff education and procedural consultation.   The Aortic Intervention division of Cook Medical focuses on the Endovascular treatment solutions for abdominal and thoracic aortic disease.   Product line includes endovascular grafts and accessory devices (wire guides, catheters, dilators, introducers, and molding balloons) to support implant procedures.   For more information about Cook Medical, visit www.cookmedical.com       Responsibilities • Provide clinical support during procedures • Identify, establish, support and develop relationships with key   clinical and non-clinical decision-makers to clinically support company   product lines • Educate and update customers through in-servicing training, literature,   videos and articles approved by the company • Provide clinical...

Product Sales Specialist - Recon based in Singapore Life Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living.   Achievement of territorial sales budget, profit and market share in line or exceeding the company’s objectives through the execution of approved Sales and Marketing Plans and effective control of assigned territories. What will you be doing? Meets or exceeds established annual sales quota. Initiates sales process by prospecting, scheduling of appointments, conduct sales presentations, understanding business needs, develop proposals and sales closure. Expands sales in existing accounts by introducing additional solutions and services and /or develop new and innovative applications. Closes sales by establishing rapport with potential customers, expounding on the benefits of business unit solutions and service capabilities; overcoming objection, etc. Proactively keeping up to date on product knowledge...

Career Category Quality Job Description ABOUT AMGEN   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.   Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.  ABOUT THE ROLE   In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations.   You will make key contributions to ensure high quality and right first time materials are received at...

Career Category Quality Job Description Specialist – QA Technical Support NPI Live    What you will do    Let’s do this. Let’s change the world.  Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.  The Quality Assurance Technical Support Specialist NPI (New Product Introduction) is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of...

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....

Career Category Engineering 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....

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....

Within this role you will be responsible for providing technical support on the manufacturing process. You will be a key member in the implementation of large scale commercial manufacturing production program and heavily involved in the technical transfer of processes. This is a shift position, including day and night shift.  As a Process Specialist Downstream, a typical day might include, but is not limited to, the following: Liaising with the process science/technology transfer teams in relation to the transfer and startup of the downstream manufacturing process Being the key person for technical input into manufacturing records, batch sheets and procedures Writing and reviewing, Standard Operating Procedures or other controlled documents as needed Providing technical input to resolve process problems both on and off the production suites Working closely with other cross functional groups such as Maintenance, Process Sciences, Engineering to resolve...

We are currently looking to fill a Principal Quality Compliance Specialist to join the Quality Assurance Change Control Business Process Team. The Quality Compliance Specialist ensures adherence to cGMPs , internal, external, and international requirements with respect to change control activities. This role is integral to facilitating process improvements, ensuring robust training for system end users, and supporting the Quality Management System.     As a Principal Quality Compliance Specialist, a typical day might include the following:   Developing and executing a comprehensive training strategy for the change control quality system.   Leading training for end users of the Change Control System.   Partnering with counterparts to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process and associated procedures.   Sponsoring and advocating for...

We are currently looking to fill a Quality Assurance Specialist position to support the Manufacturing Execution System (MES). This position will support a cross functional team of MES Specialists by providing a QA perspective with regards to manufacturing business processes, documentation requirements, and overall design of records. We are looking for someone who can continuously provide QA input and feedback in accordance with regulations, policies and procedures. In this role, a typical day might include the following: Reviewing company documentation including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records to assess MES impact Identifying difficulties and suggesting alternatives that are aligned with QA Reviewing MES change controls and test plans Working with Technical Trainers to develop QA training plans for MES users Collaborating in the creation, review, and approval of validation documents Reviewing and approving MES recipes, master...