Senior Associate Quality Assurance

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.

Senior Associate Quality Assurance

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff, and also to provide coaching, guidance and direction to Manufacturing, Quality Control, and Facilities/Engineering staff regarding compliance and quality systems. This position works a rotating day shift (B shift), with five days worked during one week (M, Tu, F, Sa, Su) and two days the following week (W, Th). Shift hours are 7am to 7pm.

• Provide Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.

• Provide Quality oversight during on-the-floor analytical testing.

• Ensure that facilities, equipment, materials, processes, and procedures follow cGMPs and other applicable regulations.

• Ensure that changes that could potentially impact product quality are assessed according to procedures.

• Ensure that deviations from established procedures are investigated and documented per procedures.

• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

• Perform review and approval of cGMP processes, procedures, and records, including but not limited to, Standard Operating Procedures (SOPs), batch records, deviations, and logbooks.

• Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports.

• Alert senior management of potential quality, compliance, supply, or safety risks.

• Complete assigned training to permit execution of required tasks.

• Drive operational improvement initiatives, programs, and projects.

• Perform other tasks, as assigned, to assist in completion of activities associated with the attainment of group, departmental, and company goals.

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 self-starter with these qualifications.

Basic Qualifications:

• High school/GED + 4 years Quality/Manufacturing work experience OR

• Associate’s + 2 years Quality/Manufacturing work experience OR

• Bachelor’s + 6 months Quality/Manufacturing work experience OR

• Master's

Preferred Qualifications:

• Bachelor’s degree and 2 years of Quality/Manufacturing work experience

• Experience working in a cGMP environment

• Experience with decision making

• Experience with analytical testing and/or general compendia testing

• Experience working with batch records and other GMP documentation

• Knowledge of data integrity requirements

• Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)

• Experience collaborating within and across functional areas and demonstrated customer service focus

• Excellent written and verbal communication skills

• Ability to prioritize and navi