National Guard Employment Network
Senior Associate Quality Control - Holly Springs, NC
National Guard Employment Network, Holly Springs, North Carolina, United States, 27540
Senior Associate Quality Control - Holly Springs, NC
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 follow the next steps. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives 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 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
What you will do: Perform testing and assist with managing the Quality Control Bioassay laboratory. Assist with planning and execution of equipment installation and qualification within the Bioassay lab to support startup. Responsible for operating QC bioassay analytical testing for biologic products which includes ELISA and cell-based methods. Leading transfer, qualification, and/or validation for the complex biologic procedures. Author, revise, and review documents and reports including SOPs, safety assessments, methods, trend reports, qualification/validation summary reports, technical reports, and method assessments. Assist with planning, scheduling, and execution of daily activities. Work with external partners to ensure successful transfer and release of and stability testing. Support all operations of the Bioassay lab including the ordering of supplies, maintaining of equipment and lab spaces. Participate in audits, initiatives, and projects that may be interdepartmental or global in scope. Own, manage, and participate in deviations, CAPAs, and cross functional investigations. Training of junior staff in bioassay techniques and assays. Assist with general lab setup and 5S. Support routine activities over the weekends and Amgen holidays as needed. Qualifications
What we expect of you: We are all different, yet we all use our unique contributions to serve patients. The Specialist Quality Control Bioassay we seek is a dynamic, flexible, and driven individual with the following qualifications: Basic Qualifications: High school diploma / GED and 4 years of Quality Analytical testing experience OR Associate's degree and 2 years of Quality Analytical testing experience OR Bachelor's degree and 6 months of Quality Analytical testing experience. Preferred Qualifications: Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements. Degree in immunology, Biology, Biochemistry, or related scientific field. Experience with cell-based methods and ELISA's, with strong data analysis skills. Experience with equipment validation. Strong knowledge of aseptic technique. Strong written and verbal communication skills, including technical writing and technical presentations. Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer. What you can expect of us
From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Salary Range $81,082.00 USD - $98,151.00 USD
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 follow the next steps. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives 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 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
What you will do: Perform testing and assist with managing the Quality Control Bioassay laboratory. Assist with planning and execution of equipment installation and qualification within the Bioassay lab to support startup. Responsible for operating QC bioassay analytical testing for biologic products which includes ELISA and cell-based methods. Leading transfer, qualification, and/or validation for the complex biologic procedures. Author, revise, and review documents and reports including SOPs, safety assessments, methods, trend reports, qualification/validation summary reports, technical reports, and method assessments. Assist with planning, scheduling, and execution of daily activities. Work with external partners to ensure successful transfer and release of and stability testing. Support all operations of the Bioassay lab including the ordering of supplies, maintaining of equipment and lab spaces. Participate in audits, initiatives, and projects that may be interdepartmental or global in scope. Own, manage, and participate in deviations, CAPAs, and cross functional investigations. Training of junior staff in bioassay techniques and assays. Assist with general lab setup and 5S. Support routine activities over the weekends and Amgen holidays as needed. Qualifications
What we expect of you: We are all different, yet we all use our unique contributions to serve patients. The Specialist Quality Control Bioassay we seek is a dynamic, flexible, and driven individual with the following qualifications: Basic Qualifications: High school diploma / GED and 4 years of Quality Analytical testing experience OR Associate's degree and 2 years of Quality Analytical testing experience OR Bachelor's degree and 6 months of Quality Analytical testing experience. Preferred Qualifications: Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements. Degree in immunology, Biology, Biochemistry, or related scientific field. Experience with cell-based methods and ELISA's, with strong data analysis skills. Experience with equipment validation. Strong knowledge of aseptic technique. Strong written and verbal communication skills, including technical writing and technical presentations. Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer. What you can expect of us
From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Salary Range $81,082.00 USD - $98,151.00 USD