Sr Associate Quality Control I

About the role

Join Amgens 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.

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.
• Data review for activities performed within the Microbiology department.
• Auxiliary 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.
• 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.

Requirements

• High school/GED + 4 years of related GxP laboratory work experience OR Associates + 2 years of related GxP laboratory work experience OR Bachelor's + 6 months of related GxP laboratory work experience OR Master's
• Related experience in the pharmaceutical industry, preferable 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.

Qualifications

• Basic Qualifications
• Preferred Qualifications

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.

In addition to the base salary, Amgen offers a total rewards plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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.

Refer to the Work Location Type in the job posting to see if this applies.

Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.