Career Category

Job Description

Role Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

We are seeking to appoint well-qualified and experienced individual to assume the role of Associate Quality Control.

Responsibilities:

• Perform analytical testing of in-process control, drug substance intermediate, final release, stability and plant cleaning samples in a GMP pharmaceutical environment.
• Support laboratory operations including but not limited to equipment qualification, calibration, cleaning and maintenance, reagent/ buffer preparation.
• Responsible for maintenance of chemicals and consumables inventory.
• Ensure proper handling, storage, disposal of all chemicals used in the lab.
• Responsible for laboratory housekeeping and document archival duties.
• Participate in laboratory investigations and assist in timely closure of investigations, CAPAs and deviations.
• Participate in method verification and method validation/ transfer for new product introduction (when required).
• Perform review of laboratory data/ records.
• Assist in SOP/ protocol/ report writing.
• Assist in periodic review of laboratory procedures and risk assessment.
• Support audit preparation and any audit related activity.
• Participate in continuous improvement initiatives and projects.
• Any other tasks assigned by the QC Manager

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Basic Qualifications

• Bachelor’s Degree in Chemistry, Biochemistry, Life Science or related technological field and 2 years of directly related experience OR
• Associate’s Degree in Chemistry, Biochemistry, Life Science or related technological field and 4 years of directly related experience OR
• High School Diploma in Chemistry, Biochemistry, Life Science or related technological field / GED and 6 years of directly related experience

Preferred Qualifications

• 1-2 years of relevant laboratory experience in the commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
• Knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods.
• Experience with Quality Control testing and laboratory operations for common testing methods and equipment (e.g. including but not limited to UPLC, HPLC, LC-MS, GC-HS, LOD, Autotitration, KF, Optical Rotation, wet chemistry, FT-IR, pH, conductivity, TOC, Potency, ELISA, Capillary Electrophosis, DNA Testing)
• Good communication skills (technical writing and verbal communication/ presentation)
• Interact effectively with variety of communication and working styles and ability to work well in teams
• Ability to manage multiple simultaneous activities in a rapidly changing environment
• Problem solving skills and troubleshooting skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

Additional Requirements

• Work on shift schedules may be required