Associate Quality Control - TIM Lab Analyst

Associate Quality Control - TIM Lab Analyst

Join Amgen's mission of serving patients living with serious illnesses. Since 1980, Amgen has pioneered biotech to fight the world’s toughest diseases. As a member of the Amgen team, you’ll help make a lasting impact on patients’ lives by researching, manufacturing, and delivering innovative medicines.

In this vital role you will primarily provide testing of HPLC and CE assays and ensure quality and operational excellence within the HPLC/CE team at the Amgen Thousand Oaks Site. Responsibilities include performing sample testing and approval, performing supporting activities such as SOP/method revision, equipment validation, method transfers, and general troubleshooting. This role may also perform additional testing such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH.

The environment is challenging, fast‑paced and ever‑changing with varying degrees of process definition, but very rewarding for those who like hands‑on science and want to make relevant improvements in the QC space.

• Report, evaluate, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with team members.
• Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Complete protocols and perform assay transfer/validation and equipment qualification/verification.
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• Responsible for CEMS on call pager.
• May participate in lab investigations.
• May provide technical guidance.
• May train others.
• May represent the department/organization on various teams.
• May interact with outside resources.
• cGMP Experience.
• Experience in Capillary electrophoresis.
• Experience using Empower CDS, LIMS and/or Smart Lab.
• Experience using Waters H-Class UHPLC and Agilent HPLC instrumentation.
• Experience and knowledge of Data Integrity Requirements of QC Systems.
• Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint).
• Excellent problem‑solving capabilities and attention to detail.
• Experience of collaboration within and across functional areas and outstanding customer service focus.
• Excellent written and verbal communication skills.

• Performing routine laboratory procedures.
• Routine analytical testing.
• Documenting, computing, compiling, interpreting, and entering data.
• Maintaining and operating specialized equipment – initiating and/or implementing changes in controlled documents.
• Must learn and follow safety guidelines and cGMPs/CFRs including maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks.

• High school/GED + 2 years quality control work experience OR
• Associate's degree + 6 months quality control work experience OR
• Bachelor's degree.

• Ability to adhere to regulatory requirements, written procedures and safety guidelines.
• Ability to evaluate documentation/data according to company and regulatory guidelines.
• Ability to organize work, handle multiple priorities and meet deadlines.
• Strong written and oral communication skills.
• Must be detail oriented.
• Must be flexible and adaptable to changing priorities and requirements.
• Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance.
• Demonstrates understanding of when and how to appropriately escalate.
• May identify, recommend and implement improvements related to routine job functions.
• Must learn and align with safety guideline and cGMPs.

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, including health and welfare plans, financial plans, work/life balance, and career development…