Aseptic Officer
- Employer
- Amgen
- Location
- Thousand Oaks, CA
- Start date
- Mar 29, 2023
View more
- Discipline
- Manufacturing & Production, Manufacturing/Mechanical, Operations, Science/R&D, Microbiology
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
LiveWhat you will do
Lets do this! Lets change the world! In this vital role you will be responsible for the manufacturing aseptic technique program including routine observation of critical processes, coaching and mentoring on aseptic technique, trending of observations, implementation of corrective actions, and ownership of the environmental monitoring (EM) heat map. B20 Manufacturing representative for the Environmental Monitoring Program, partnering with Quality Control program owner and Quality Assurance Aseptic Officer on review of data trend reports, metrics, EM protocols/reports, SOPs, interacting with and/or presenting to internal and external inspectors, and supporting non-conformance investigations.
Aseptic Officer Program Owner
Execute routine observations of aseptic processes, trend the observations and lead corrective actions as required
Provide coaching and mentoring on aseptic technique
Create and review relevant procedures for completeness and accuracy
Partner with Quality Assurance Aseptic Officer
Partner with Aseptic Officers at other sites
Must align with safety guidelines
Must align with cGMPs/CFRs which includes, but is not limited to, the maintenance of training records and written procedures.
Provide technical support for evaluating changes and impact on the Environmental Monitoring program
Support the review/approval of EM data trend reports, metrics, EM protocols/reports, SOPs
Interact with and/or present to internal and external inspectors
Support non-conformance investigations
Provide environmental monitoring input on assessment of change control records as required
Support non-conformances and investigations as a subject matter expert
Own and participate in Lean Transformation activities (e.g., SQDIP boards, Work Center Teams)
Champion improvement opportunities cross functionally and use continuous improvement tools and methodology, (e.g. 5S, Kaizen, Smart Ideas)
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 an employee with these qualifications.
Basic Qualifications:
Doctorate degree
OR
Masters degree and 3 years of operations or quality experience
OR
Bachelors degree and 5 years of operations or quality experience
OR
Associates degree and 10 years of operations or quality experience
OR
High school diploma / GED and 12 years of operations or quality experience
Preferred Qualifications:
10 years of bio-pharmaceutical and/or medical technology experience with increasing responsibility in the organization
A Bachelor's or Master's degree in Microbiology, Life Sciences or a related field
Experience working in an aseptic environment. Technical problem solving, negotiation and communication skills. Perform investigations and create presentations
Experience working in or supporting a Manufacturing environment. Attention to detail and team oriented. Able to organize work, handle multiple priorities, and meet deadlines. Flexible and adaptable to changing priorities and requirements and knowing when to escalate.
Experience working with internal and external inspectors
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.
The annual base salary range for this opportunity in the U.S. is $102,767 - $122,434.
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:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
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 bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comJoin 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 cancers, 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.
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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