QC Microbiology Tech II - 1 of 2

Descrizione del lavoro

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

As a QC Microbiology Tech II, at Gilead you will ...

Key responsibilities

• Performs environmental and/or utility monitoring and sampling as a primary function.
• Performs routine and non-routine collection and testing of raw materials, intermediates, final product, validation-related, and critical utility samples according to SOPs.
• Receives, quarantines, and stores purchased microbiological media pending laboratory release. Monitors bio hazardous waste and coordinates its removal with qualified safety personnel.
• Participates in validation and commercial/developmental manufacturing activities.
  Reviews and issues Environmental Notifications based on raw data, and validated electronic data acquisition systems.
• Represents QC for area of specialization in site meetings.
• Supports testing of solid oral dosage, packaging component testing, raw material and sterile product testing.
• Troubleshoots standard instrumentation/test methods.
• Performs activities in support of final product release testing (e.g. tests applicable for endotoxin, sterility, and toxicity) and raw material testing (e.g. microbial limits, endotoxin, and potency) where required.
• Performs activities in support of environmental monitoring including surface viable air, non-viable air and personnel monitoring.
• Performs activities in support of bioburden testing of water and product; and conductivity and chemical testing of compressed gases

Basic qualifications:

• 2+ years of relevant experience and a High School diploma.
• Relevant experience including internship with a BS degree, or degree in related field.

Preferred qualifications

• Prior experience in biopharmaceutical or pharmaceutical industry preferred.
• Prior lab experience preferred.
• Basic Knowledge of current Good Manufacturing Practices (GMPs)
• Basic Knowledge of general Microbiology techniques such as gram staining, aseptic technique, and plate streaking technique.
• Knowledge of USP and other regulatory requirements.
• Proficiency in Microsoft Office applications.
• Ability to work effectively in a team environment.
• Strong verbal, written, and interpersonal communication skills are required.
• LIMS proficiency.
• Technical training on environmental monitoring of facility and utility system.