Manager Quality Control
- Employer
- Amgen
- Location
- Thousand Oaks, California
- Start date
- Feb 1, 2025
View more categoriesView less categories
- Discipline
- Quality, Quality Control
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Quality Control Manager
What you will doLets do this. Lets change the world. In this vital role will be responsible for supervision of all technical and operational activities within the QC Bioassay Laboratory at Amgen, Thousand Oaks.
Responsibilities:- Oversees the execution of testing including routine analysis, cell bank Stability and testing in support of technology transfer for analytical methodologies
- Provides Bioassay technical expertise/guidance to lab staff and within cross-functional Amgen teams
- Manages the Bioassay Lab daily operations in relation to planning and management of materials, critical reagents, equipment and laboratory staff
- Owns and reviews controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to Bioassay Lab activities
- Ensures that the Bioassay Lab operations comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and Laboratory Controls.
- Represents the Bioassay Lab during Amgen internal/external audits and inspections. Direct interaction with regulatory agencies during on-site inspections.
- Provides oversight of Bioassay Lab Quality Systems records including Deviations, CAPAs and Change Controls
- Selects, develops and evaluates laboratory staff to ensure functional objectives are met
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
Doctorate degree
OrMasters degree and 3 years of Bioassay experience
OrBachelors degree and 5 years of Bioassay experience
OrAssociates degree and 10 years of Bioassay experience
OrHigh school diploma / GED and 12 years of Bioassay experience
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
- Advanced Degree in Scientific Discipline
- Strong knowledge in Bioassay Laboratory techniques
- Familiarity with the technology transfer process. Experience with validating analytical methods and ensuring that project deliverables meet established timelines.
- Strong level of analysis skills to evaluate and interpret data to arrive at logical and quality-minded conclusions. Experience applying problem-solving tools for root cause analysis.
- Proven leadership capabilities and experience applying GMP requirements in a Quality Control setting
- Demonstrated ability to develop, coach and mentor employees
- Excellent interpersonal, verbal and written communication skills with all levels within the organization
- Experience with successfully managing a team and delivering results in fast-paced and dynamic work environment
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, well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
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 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
- Flexible work models, including remote and hybrid work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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. 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.
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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