Amgen

Sr. Associate Quality Control

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Mar 26, 2019
Ref
R-73616
Discipline
Quality, Quality Control
Required Education
Masters Degree/MBA
Position Type
Full time
A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

The Sr. Associate Quality Control will support the QC Immunoassay and General Testing team by performing testing and data review/approval for ELISA methodology assays, qPCR, Karl Fisher Moisture, GC (Gas Chromatography), BLE (Breakloose and Extrusion) and UV Vis. Staff member may also perform additional testing such as Viscosity, Osmolality and Reconstitution Time.

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.
  • Participate in lab investigations.
  • Provide technical guidance.
  • Provide training to 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 Immunoassay (ELISA methodology)
  • Experience using Empower CDS, LIMS and/or SmartLab
  • Experience and knowledge of Method Transfer and Validation Process
  • 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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.