Sr. Quality Assurance Engineer
3 weeks ago
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
You've 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 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Sr. Quality Assurance Engineer
Live
What you will do
Let's do this. Let's change the world. In this vital role you will be accountable to provide Quality oversight of CPO method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to CPOQ CORE and/or to sites. Ensures successful physical method development critical to achieving reliable data, considering impact of risk to patient, global compliance and time to market. Ensures alignment strategies for methods transfer across multiple sites.
Responsibilities:
Co-develop training materials for stability method transfers with CPO
Ensures activities are in line with budget and support evidence-based resource needs
Provides Quality oversight to CPO activities and results (A)
Quality approval of protocols and technical reports for method development (D)
Provides advice to inform Quality Plan (A)
Provides advice and expertise to inform development of technical training materials for method transfer (A)
Oversight of protocols and requirements to outsource testing to labs (A)
Approved method development, validation, and transfer reports
Robust change controls, CAPAs, and NCs
Successful CPO method stewardship deliverables
Method training materials
Reports to manager CPOQ Core in Thousand Oaks.
Key advisor to Core Technologies Lead
Advisor to Innovation and Development Leads
Advisor to site quality organizations
Advisor to Product Quality Leaders (PQLs)
Collaborate with and/or provide advice to Regulatory to inform submissions
Align with Attribute Sciences where similar networks or governances are established
Collaborate with External Supply Quality to ensure plans in place when receiving methods from a CMO or suppliers
Additional Qualifications/Responsibilities
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
Master's degree and 2 years of quality experience
Or
Bachelor's degree and 4 years of quality experience
Or
Associate's degree and 8 years of quality experience
Or
High school diploma / GED and 10 years of quality experience
Preferred Qualifications:
10+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor's Degree in a Science Field
Experience in developing physical methods for combination products
Familiarity with force measurement equipment, dimensional analysis, calibration, and lab GLP
Leadership skills and the ability to coordinate multiple projects simultaneously
Familiar with combination products including applicable guidance, regulations and standards e.g. ISO 14971, ICH Q8, ICH Q9, ICH Q10, ICH Q12, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211Working knowledge of calibration standard ISO 17025
Ability to discern user requirements for input to method development
Able to successfully manage workload to timelines
Thrive
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 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.
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
Salary Range
109,439.00 USD - 128,989.00 USD
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