at Amgen
Location
US - Puerto Rico - Juncos
Posted
2 days ago
Market range · company + function + seniority
p25 · target · p75 · n=209
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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 Assurance
Let’s do this. Let’s change the world. In this vital role you will ensure the integrity and compliance of materials and processes that support the delivery of high-quality, life-impacting products.
Specific responsibilities include but are not limited to:
Perform inspections, testing, and release activities independently, ensuring strict adherence to SOPs, cGMPs, and safety protocols.
Apply subject matter expertise in materials and/or production processes to identify quality issues and ensure compliance.
Accurately complete documentation in accordance with Good Documentation Practices, and contribute to SOP improvements when needed.
Analyze data and documentation to detect trends or potential quality issues, escalating appropriately and supporting resolution efforts.
Communicate clearly and promptly with manager when tasks deviate from plan, providing updates and rationale as needed.
Manage workload effectively by aligning daily tasks with business priorities and deliverables, while adapting to changing demands.
Use digital tools (e.g., Smartsheet) to track task progress and ensure timely completion of quality activities.
Share knowledge and best practices with peers and new team members to support team development and continuous improvement.
Seek clarification from subject matter experts when technical gaps arise, and engage in learning opportunities.
Demonstrate a strong quality mentality by modeling integrity, consistency, and accountability in all aspects of work
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Sr. Associate Quality Assurance professional we seek is an individual contributor with these qualifications.
Basic Qualifications:
Master's Degree
Or
Bachelor’s Degree + 6 months of Quality Assurance work experience
Or
Associate’s Degree + 2 years of Quality Assurance work experience
Or
High school/GED + 4 years of Quality Assurance work experience
Preferred Qualifications:
Educational background in Life Sciences or Engineering
Basic statistical mathematical skills
Basic knowledge of process and facility equipment
Knowledge in systems like Trackwise, Electronic Batch Record (EBR), SAP, LIMS
GMP knowledge with ability to interpret and apply in routine cases
Technical writing capability in English
Proven skills in problem solving and providing solutions
Ability to interface efficiently with various levels
Basic understanding of analytical methods used in support of facility process monitoring
Ability to work as a team player and/or independently
Ability to evaluate documentation/ operations according to company guidelines
Intermediate word processing, database, presentation and spreadsheet application skills
Skill in prioritizing and meeting deadlines
Good communication and presentation skills (both written and verbal in English)
Bilingual English-Spanish
Independently understand, follow and implement instructions
Ability to seek outside resources as needed
Demonstrate the Amgen Values
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.
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 & vision coverage, and life & disability insurance
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.
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information
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.
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