Amgen

Sr. Associate Mfg

Employer
Amgen
Location
Juncos, PR, US
Posted
Apr 08, 2021
Ref
R-115731
Required Education
Other
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Sr. Associate Mfg - Deviation and Data Management

Live

What you will do

Let's do this. Let's change the world! In this vital role you will support the enforcement of manufacturing/quality systems specific to the investigation and reduction of deviations in the Drug Product Manufacturing - Inspection & Packaging and Solid Dosage Operations. Will apply process, operational, scientific expertise, compliance knowledge, and analytical skills. Will also support the deviation process and robust CAPA identification for manufacturing operations and support systems. In addition will perform data analysis and verification in support to improvement and trending process.

Specific responsibilities include but are not limited to:

 

  • Deliver timely & complete deviation records documentation that can include root cause analysis and define CAPAs.
  • Capable of understanding process monitoring parameters and control limits require to assess for potential causal factors.
  • Capable of generate/analyze/report data using Excel, Power Point, and other business tools. Also, basic knowledge in visualization tools for data management purpose.
  • Assess process performance by observation of floor operations and review of performance data.
  • Support troubleshooting to identify Causal Factors and potential corrections
  • Evaluate manufacturing & operational procedures and training requirements for technical aspects of the process and process improvement opportunities.
  • Use risk assessments as needed to identify and understand risks and failure modes.
  • Perform Impact to Process /Equipment /System Assessment.
  • Team with Product Development and other functional areas to understand potential impact to product quality attributes and negotiate actions with partners.
  • Assess Equipment/Systems information for potential impact to product quality attributes.
  • Assess for Data Integrity and Process Validation Impact and be the author of investigation reports.
  • Apply technical writing techniques proficiently, perform data verification, support peer review and ensure timely report approval.
  • Participate in regulatory inspections.


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Sr Associate Mfg professional we seek is an Individual Contributor with these qualifications.

Master's degree

OR

Bachelor's degree & 2 years of manufacturing experience in a GMP regulated industry.

Beyond that, additional preferred qualifications are:

 

 

  • Educational background in Life Science and/or Engineering.
  • Experience in Biopharmaceutical, Medical Devices or Pharmaceutical industry
  • Excellent written and verbal communication skills in English and Spanish
  • Strong Technical Writing Skills
  • Knowledge and experience in Root Cause Analysis (Fishbone, Six Boxes, Fishbone, 5 Why's, Kepner Tregoe).
  • Detailed technical understanding of bio-processing unit operations.
  • Compliance/Regulatory knowledge and audit interaction experience.
  • Experience leading cross-functional teams for Root Cause Analysis and problem solving
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
  • Strong presentation and project management skills.
  • Knowledge of control charting, data management/analysis, data verification
  • Availability to support non-standard shift.

 


Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.

 

 

 

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

 


Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us: careers.amgen.com

Equal Opportunity Statement

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 a 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 an accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.