Amgen SA
Sr Associate Quality Assurance
Amgen SA, Thousand Oaks, California, United States, 91362
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 Associate Quality AssuranceLive
What you will doLet’s do this. Let’s change the world. In this vital role you will support the Amgen’s Drug Product Quality Assurance team under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities and Engineering staff in the execution of their processes, procedures, and use of quality systems.Responsibilities:
Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.Provide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.Strong purposeful presence on the manufacturing floor.Perform Electronic Batch Record Review.Provide Maximo support and work order approval.Participate in and provide quality oversight for quality records including Deviations and Change Controls, assuring adherence to procedural requirements and regulatory expectations.Provide quality expertise and guidance to operational staff and within cross functional Amgen teams.Review and approve controlled documents, including Standard Operating Procedures, Protocols and Reports.Ensure that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.Contribute to and drive continuous improvement projects in cross-functional collaboration.Participate in Amgen internal/external audits and inspections. May directly interact with regulatory agencies during on-site inspections.Win
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go-getter with these qualifications.Basic Qualifications:
High school/GED + 4 years Quality experience ORAssociate’s + 2 years Quality experience ORBachelor’s + 6 months Quality experience ORMaster's.Preferred Qualifications:
Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field.Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.Experience managing projects through to completion meeting timelines.Ability to evaluate documentation and operations according to company procedures.Experience working with Quality Systems.Strong organizational skills and ability to manage multiple tasks at one time.Effective communication skills (both written and verbal).Demonstrated ability to work as both a team player and independently.Display leadership attributes and drive improvement initiatives.Solid understanding and application of aseptic behaviors and principles.Thrive
What you can expect of usAs 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.Apply now
for a career that defies imagination.Objects in your future are closer than they appear. Join us.careers.amgen.com
Application deadline
Amgen 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.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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What you will doLet’s do this. Let’s change the world. In this vital role you will support the Amgen’s Drug Product Quality Assurance team under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities and Engineering staff in the execution of their processes, procedures, and use of quality systems.Responsibilities:
Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.Provide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.Strong purposeful presence on the manufacturing floor.Perform Electronic Batch Record Review.Provide Maximo support and work order approval.Participate in and provide quality oversight for quality records including Deviations and Change Controls, assuring adherence to procedural requirements and regulatory expectations.Provide quality expertise and guidance to operational staff and within cross functional Amgen teams.Review and approve controlled documents, including Standard Operating Procedures, Protocols and Reports.Ensure that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.Contribute to and drive continuous improvement projects in cross-functional collaboration.Participate in Amgen internal/external audits and inspections. May directly interact with regulatory agencies during on-site inspections.Win
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go-getter with these qualifications.Basic Qualifications:
High school/GED + 4 years Quality experience ORAssociate’s + 2 years Quality experience ORBachelor’s + 6 months Quality experience ORMaster's.Preferred Qualifications:
Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field.Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.Experience managing projects through to completion meeting timelines.Ability to evaluate documentation and operations according to company procedures.Experience working with Quality Systems.Strong organizational skills and ability to manage multiple tasks at one time.Effective communication skills (both written and verbal).Demonstrated ability to work as both a team player and independently.Display leadership attributes and drive improvement initiatives.Solid understanding and application of aseptic behaviors and principles.Thrive
What you can expect of usAs 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.Apply now
for a career that defies imagination.Objects in your future are closer than they appear. Join us.careers.amgen.com
Application deadline
Amgen 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.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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