Sr Specialist Supply Chain QA
1 week ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Senior Specialist Supply Chain QALive
What you will do
Lets do this Lets change the world
Provide Quality Assurance strategic collaboration with global distribution and supply chain leaders. Ensure compliance to GMP regulations for area operations and associated processes, including warehousing and distribution, inventory management, and management of external relationships with Logistics Service Providers like storage depots and transportation service providers.
Typical tasks include:
Partner with Supply Chain leaders to develop clinical supply chain future strategy.
Assess product distribution risks and develop post-distribution inventory control plans in response to emergent quality defects identified through internal deviations, external complaints or clinical site events.
Provide veteran QA guidance for supply chain teams executing transformation initiatives, including integrations following mergers and acquisitions, supply chain improvement projects, novel clinical trial designs and distribution expansion initiatives.
Internal Quality Assurance support for GMP warehouse and inventory management operations
Support high risk investigations/deviations
Internal Quality Assurance support for creation and revision of GMP procedures and record generation, including document review, approval, and archival
The successful candidate will have experience working in multiple GMP databasesWin
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 individual with these qualifications.Basic Qualifications:
Doctorate degree and 2 years of quality, supply chain or distribution experience OR
Masters degree and 4 years of quality, supply chain or distribution experience OR
Bachelors degree and 6 years of quality, supply chain or distribution experience OR
Associates degree and 10 years of quality, supply chain or distribution experience OR
High school diploma / GED and 12 years of quality, supply chain or distribution experiencePreferred Qualifications:
3+ years of experience in a Quality Assurance role supporting GMP operations
Strategic vision and collaborative attitude to develop business balanced and compliant supply chain strategies
Previous experience with quality system transactions (SAP, LIMS, Trackwise, Veeva)
Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent
Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and adhering to good documentation practices.
Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry
Proficient with database use, including data input, archival, and query retrieval
Great attention to detail and high degree of accuracy in task execution and GMP documentation
Highly effective verbal and written communication skills, strong interpersonal skills
Ability to complete tasks autonomously, provide updates to area manager, and identify potential issuesThrive
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 possibleApply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.
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