Description

• Support 12-hour rotating day shift (8am-8pm), inclusive of weekends and public holidays.
• Responsibilities may include but are not limited to:
• Execute testing and/or review, such as routine environmental, water, raw material and product testing (e.g. bioburden, endotoxin, qPCR, microbial ID etc.); media, reagent and culture qualification (e.g. growth promotion, DNA positive controls, microorganisms culture types etc.).
• Sample management which includes logging of samples, movement and storage of samples, reconciliation of sample receipt, aliquoting of samples, management of stability samples, and shipment of samples to Amgen network sites and/or contract labs.
• Involvement in document revisions and report writing.
• Involvement in equipment installation commissioning and qualification, calibration and maintenance.
• Involvement in method transfers, method validation/verification and sample type qualification.
• Laboratory housekeeping and document archival.
• Project management / Involvement in QC projects (e.g. Continuous Improvement/ Operational Excellence)
• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.

Qualifications

• Bachelor’s degree in Microbiology, Biological Sciences, Life Sciences or related technological field and 2 years of directly related experience OR
• Associate’s Degree in Microbiology, Biological Sciences, Life Sciences or related technological field and 4 years of directly related experience
• High School Diploma in Microbiology, Biological Sciences, Life Sciences or related technological field / GED and 6 years of directly related experience
• 1-3 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry, biopharmaceutical production and 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 microbial testing methods and equipment (e.g. including but not limited to bioburden, endotoxin, microbial identification, environmental monitoring, microbial limits, growth promotion, biological indicators).
• GMP laboratory operation including conducting sample management and 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 with the ability to apply logic and assess data to reach decisions and solutions related to assay suitability and comparability.