Sr. Associate Quality Assurance AML 14 - Night Shift
Amgen
US - Puerto Rico - JuncosPosted about 1 month agoDiscoveredMatch locked
Full time
Career Category
Quality
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.
What you will do
Let’s do this. Let’s change the world. In this vital role, you will be part of a department that provides 24/7 operational support through non-standard work schedules, including weekends and holidays. In this 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
- Responsible for providing on-site support to manufacturing areas and Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations
- Ensures that facilities, equipment, materials, organization, processes, procedures and products stay in sync with cGMP, cGLP practices, and other applicable regulations
- Actively engage in Continuous Improvement initiatives, programs and projects
- Ensures that changes that could potentially impact product quality are assessed according to procedures
- Ensures that deviations from established procedures are investigated and detailed per procedures
- Ensures that production records and testing results are complete, accurate, and detailed according to written procedures, cGMP, and cGLP requirements
- Participate in internal plant audits
- Assist in Investigations
- Perform sampling plans for all manufactured products, batch records review, SAP transactions, Trackwise system queries, deviations management and Veeva System queries
- Participate in triage process and Decision Making Process (DAI)
- Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies
- Work with operations to resolve basic compliance discrepancies
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
High school/GED and 4 years of quality Assurance work experience
OR
Associate’s and 2 years of quality Assurance work experience
OR
Bachelor’s and 6 months of quality Assurance work experience
OR
Master's Degree
Preferred Qualifications
- Educational background in Life Sciences or Engineering.
- GMP knowledge with ability to interpret and apply in routine cases.
- Experience with Trackwise, EBR, SAP, DQMS, LIMS systems and Veeva Systems.
- Strong technical writing and communication skills in English; bilingual (English/Spanish).
- Ability in problem-solving and providing solutions.
- Ability to evaluate documentation and operations per company guidelines.
- Intermediate proficiency in Word, Excel, PowerPoint, and database tools.
- Ability to work independently and collaboratively, prioritizing tasks and meeting deadlines.
- Basic understanding of statistical concepts and analytical methods for process monitoring.
- Ability to identify discrepancies in aseptic practices, documentation, and processes.
- Ability to communicate effectively, challenge appropriately, escalate concerns, and collaborate with Manufacturing and other functions.
- Strong critical thinking and Quality mindset with the ability to make sound, risk-based decisions.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
- 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 and an annual site shutdown
- Flexible work models where possible. Refer to the job posting to see if this applies
careers.amgen.com
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
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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
.
Not included in the source posting: benefits.
Skills
sapexcel
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
Read automatically from the employer's posting text. Always confirm with the employer — requirements can change after a job is published.