HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.Live
What you will do
Lets do this! Lets change the world!
The QA Manager will be a member of the Building 31 Plant QA team and will provide Quality oversight for the GMP Receiving function, including the review and release of incoming product and raw material shipments. The Incoming Quality Assurance (IQA) function is responsible for the review of transportation documentation, sampling of materials requiring testing for release, and the inspection and dimensional analysis of materials requiring that assessment for release. The IQA Manager will be responsible for leading and directing the IQA staff, being an informed Subject Matter Expert in IQA responsibilities, and maintaining a broad, general understanding of quality and compliance related competencies.
The QA Manager will lead in a matrixed environment with informal performance accountability to multiple functions within Building 31. He/she may represent Quality on cross functional teams to achieve departmental goals and to foster a culture of Safety in the building.Responsibilities include:
Lead and direct Quality Assurance staff, including managing their performance and supporting their development.
Provide real-time QA oversight and support for GMP Receiving operations. This currently extends to the receipt and release of product and raw material shipments in Building 31.
Collaborate with the Manufacturing team to resolve quality and compliance issues identified in the operation and to support Manufacturing process improvements.
Ensure that changes that could potentially impact product quality are assessed according to procedures (ex: site change control, Maximo)
Review and approve cGMP documents and records (e.g., Deviations, CAPAs, electronic batch record, change controls, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation
Alert senior management of quality, compliance, supply and safety risks
Support and represent Quality during audits and inspections
Support Lean Transformation and Operational Excellence initiatives
Maintain the safety of self and others, actively engages with the Amgen EHSS safety program by reporting unsafe conditions if seen and driving improvements
Ensure Quality Management System processes are executed in accordance with established procedures
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.Basic Qualifications:
Master's degree and 3 years of related experience
Bachelor's degree and 5 years of related experience
Associates degree and 10 years of related experience
High school diploma / GED and 12 years of experience and previous managerial experiencePreferred Qualifications:
Excellent interpersonal skills
Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent
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, providing updates to senior management, and identifying potential issues
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
Experience working with dynamic cross-functional teams and proven abilities in decision making
Experience in management or leadership roles
Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
Strong organizational skills, including ability to follow assignments through to completion
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Objects in your future are closer than they appear. Join us.
careers.amgen.com#Operations21Equal Opportunity Statement
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 a 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 an accommodation.
Join UsIf 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 cancer, 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.