Sr Associate Quality Control I
About The Position
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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. SR. ASSOCIATE QUALITY CONTROL I What you will do Let’s do this. Let’s change the world. In this vital role you will perform routine Microbiological testing and provide technical support for Environmental Monitoring and Utilities Monitoring programs, working at a Drug Substance manufacturing facility. The Senior Associate, Quality Control Microbiology will report directly to the Senior Manager of Quality Control Microbiology.
Requirements
- High school/GED + 4 years of related GxP laboratory work experience OR
- Associate’s + 2 years of related GxP laboratory work experience OR
- Bachelor’s + 6 months of related GxP laboratory work experience OR
- Master's
Nice To Haves
- Related experience in the pharmaceutical industry, preferrable working in a GxP Microbiology lab, or supporting GMP manufacturing operations.
- Degree in Microbiology, Biology, Biochemistry, or related scientific field.
- Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, and Environmental monitoring.
- Strong knowledge of aseptic technique.
- Strong written and verbal communication skills, including technical writing and technical presentations.
- Maintains a thorough understanding of GxP Regulations and industry standards.
- Able to flexibly work independently, as a project owner/manager, collaboratively on group tasks, and as a trainer.
- Experience owning, managing, and participating in deviations, CAPAs, and cross functional investigations.
Responsibilities
- Perform routine microbiological testing, including but not limited to endotoxin, bioburden, TOC, conductivity, and microbial identifications.
- Support sample type validation testing for microbiological assays as needed.
- Perform data review for activities performed within the Microbiology department.
- Assist EM and Utilities Program owners in tracking and trending excursions, notifying key stakeholders, and assessing remediation activities.
- Support cross functional investigations relating to EM and Utilities excursions representing the microbiology department and assist with coordinating re-sampling activities when required.
- Act as coach and mentor for junior staff and perform training for microbiological techniques and assays.
- Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
- Own, manage, and participate in continuous improvement initiatives within the QC organization.
- Represent Amgen North Carolina while participating in network forums relating to microbiological testing, Environmental monitoring, and Utilities Monitoring.
- Perform routine laboratory tasks such as cleaning and inventory management.
- Author, revise, and review documents and reports including but not limited to: SOPs, protocols, safety assessments, methods, trend reports, qualification/validation summary reports, microorganism assessments, technical reports, and method assessments.
- Own, manage, and participate in laboratory investigations, deviations, and CAPAs.
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
