Amgen Senior Associate Quality Control HPLC/CE in Thousand Oaks, California

The Senior Associate Quality Control will support the QC analytical chemistry team by performing HPLC/UHPLC (high and ultra-high liquid chromatography), titer, CEX (cation exchange), Capillary Electrophoresis (CE) and HILIC (hydrophilic interaction). Staff member may also perform additional activities such as owning Chane Control and Non-Conformance records; and additional testing support such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH.

Key Responsibilities:

  • Report, evaluate, trend and approve analytical data.

  • Troubleshoot, solve problems and communicate with stakeholders.

  • 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.

  • Execute protocols and perform assay transfer/validation and equipment qualification/verification.

  • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

  • 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

Basic Qualifications:

Master's degree OR

Bachelor's degree and 2 years of directly related experience OR

Associate's degree and 6 years of directly related experience OR

High school diploma / GED and 8 years of directly related experience

Preferred Qualification:

  • cGMP Experience

  • Experience in Capillary electrophoresis

  • Experience using Empower CDS, LIMS and/or SmartLab

  • 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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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, or disability status.

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, or disability status.