Sr. Associate QC

Career Category

Quality

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate QC

What you will do

Let’s do this. Let’s change the world. In this vital role you will under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their workday performing testing.

• Endotoxin testing of water, in-process and drug product release samples
• Bioburden testing of water & in-process drug product samples
• Sterility testing
• Water sampling
• Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
• Writing technical reports
• Media fill reconciliation and inspection
• Weekend bio burden cover
• Perform analytical testing as a main priority with efficiency and accuracy
• With a high degree of technical flexibility, work across diverse areas within the lab
• Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.
• Report, evaluate, archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• Review and Approve lab results
• May participate in lab investigations.
• May provide technical guidance.
• May train others.
• May contribute to regulatory filings.
• May represent the department/organization on various teams
• May interact with outside resources Responsibility 1

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The QC professional we seek is a collaborative individual with these qualifications.

Basic Qualifications:

• Bachelors degree in a science discipline
• Biopharmaceutical QC experience in a microbiology lab
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

Preferred Qualifications:

• Experience working in endotoxin, bioburden or sterility testing
• Proficient in GMP systems such as LIMS Labware & LMES
• Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
• Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Skills
• Take initiative to identify and drive improvements
• Excellent verbal and written communication skills
• Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
• Presentation skills
• Escalate issues professionally and on a timely basis
• Decision Making skills
• Teamwork and Coaching others
• Negotiation and Influence skills
• Problem solving skills
• Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
• Ensures compliance