Sr Associate Quality Control I

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. 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.

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.

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.

Qualifications

We are all different, yet we all use our unique contributions to serve patients. The motivated professional we seek is an experienced quality control analyst with these qualifications.

• Basic Qualifications: 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
• Preferred Qualifications: 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.

Benefits

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

• 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

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.