Senior Associate Quality Control

Amgen • Holly Springs, NC

199d • $81,082 - $98,151

About The Position

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 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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Perform testing and assist with managing the Quality Control Bioassay laboratory.
• Report directly to the Senior Manager of Quality Control Bioassay.
• Manage bioassay staff.
• Assist with planning and execution of equipment installation and qualification within the Bioassay lab to support startup.
• Operate QC bioassay analytical testing for biologic products which includes ELISA and cell-based methods.
• Lead 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.
• Train 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.

Benefits

• Competitive and comprehensive Total Rewards Plans aligned with local industry standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree