Holly Springs, NC, 27540, USA
11 days ago
Quality Control Associate - Chemistry
**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. Quality Control Associate -Chemistry **What you will do** Let’s do this! Let’s change the world! In this vital role you will be responsible for supporting the Chemistry lab start up and then performing routine testing to support the Holly Springs Facility. The laboratory employs a variety of test procedures that utilizes sophisticated equipment including Liquid chromatography, Capillary electrophoresis, and other General Chemistry methodologies such as: Concentration determination, Appearance, Color, Clarity, pH, and Osmolality. The QC Associate -Chemistry will report directly to the Sr. Manager Quality Control, Chemistry. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary. + Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements + Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks + Ensures facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations + Author, revise and review documents and reports including but not limited to SOPs, test methods, and safety assessments. + Assist with procurement activities for consumables and critical reagents for lab start up + Performs daily equipment standardizations, preps buffers, and participate in method transfer activities for general chemistry bench top equipment. + Operate laboratory equipment and instrumentation + Tests in-process materials, finished products, and stability samples by employing various quantitative and qualitative analytical techniques. + Supports Continual Improvement initiatives + Alerts management of quality, compliance, supply and safety risks + Participate in laboratory investigations + Perform general laboratory housekeeping activities + Completes required assigned training to permit carry through of required tasks + Performs additional duties as specified by management + Support routine activities over the weekends and public holidays as required. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications. **Basic Qualifications:** + High school / GED 2 years Quality experience OR + Associate’s 6 months Quality experience OR + Bachelor’s **Preferred Qualifications:** + Professional work experience in a fast-paced, flexible GxP laboratory + Demonstrated experience with various laboratory practices + Self-motivated, strong organizational skills and ability to handle multiple tasks at one time with supervision + Strong interpersonal skills (both written and oral), facilitation, and presentation skills + Demonstrate ability to be flexible and adaptable + Knowledge of pharmacopeial testing, USP (United States Pharmacopeia) and PhEUR (European Pharmacopeia). + Experience with benchtop general chemistry (protein concentration, color, appearance, pH, osmolality, titrations etc.) **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models, including remote and hybrid work arrangements, where possible **Apply now** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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