Sr Associate Quality Control

Career Category

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.

Sr Associate Quality Control

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for overseeing the quality of products and manufacturing processes. You will manage QC testing, analyze data, document results, and work closely with the production team to correct any quality issues, all while ensuring compliance with regulatory standards.

Responsibilities:

• Plan, schedule, performs analytical testing and approval of test results on raw materials, water, in-process control, drug substance and stability samples in GMP pharmaceutical environment.
• Troubleshooting issues related to analytical testing, techniques and equipment
• Conduct laboratory investigations and assist in timely closure of investigations, CAPAs and deviations
• Support method verification and method validation/transfer for new product introduction (when required)
• Train new/ junior laboratory staff and ensure all staff are appropriately trained and qualified to execute the duties assigned to them with respect to the job
• Support laboratory operations including but not limited to equipment qualification, calibration and maintenance, reagent/buffer preparation, chemicals/consumables inventory, laboratory housekeeping and document archival duties
• Perform periodic review of laboratory procedures and risk assessment.
• Author of SOPs/protocols/reports.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a go getter with these qualifications.

Basic Qualifications:

• High school/GED + 4 years of Quality, and or operations experience OR
• Associate’s + 2 years of Quality, and or operations experience OR
• Bachelor’s + 6 months of Quality, and or operations experience OR
• Master's

Preferred Qualifications:

• High school diploma / GED and 8 years of quality experience
• Preferred 4 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry and laboratory testing experience preferred.
• Strong knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods.
• Strong technical knowledge in and experience with the following QC Chemistry/ Biochemistry/ Raw material testing methods and equipment is required:
• Immunosorbent Assay/Cell based Bioassay: Potency, Host Cell Proteins, ELISA
• Chromatography: UPLC, HPLC, LC-MS, GC-HS
• General Chemistry: Capillary Electrophosis, LOD, Autotitration, KF, Optical Rotation, FT-IR, Conductivity, TOC, pH, wet chemistry
• Ability to preempt issues and disruptions to lab operations and develop mitigation actions

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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 coverag