Manager QA - AML 6
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
Amgen is looking for a Manager QA – aligned to a nonstandard work scheduled, for our multi-product mammalian cell culture facility located in Juncos, Puerto Rico. As Manager QA, the selected candidate will manage Quality staff including recruitment and performance management as well as oversee aspects of QA operations within the facility, including but not limited to on-the-floor QA support, deviation investigations, change controls, and SOP and batch record review.
What you will do
Let’s do this. Let’s change the world. In this vital role in support to Amgen’s Quality Assurance program, we are seeking a highly motivated and talented leader to join us as Manager QA, to manage and oversee the activities of the plant Quality Assurance department in our multi-product mammalian cell culture facility located in Juncos, Puerto Rico in a non-standard shift operation.Specific responsibilities include but are not limited to:
- Responsible for hiring, training, supervising and performance management of staff.
- Review and approve product MPs
- Approve process validation protocols and reports for manufacturing processes.
- Approve Environmental Characterization reports
- Approve planned incidents
- Represent Quality Assurance on New Product Introduction team
- Lead investigations
- Lead plant audits, participate in site audits
- Approve change-over completion
- May perform work of QA
- Responsible for leading and directing Quality staff for assigned plant(s) or functional area(s)
- Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP)and other applicable regulations
- Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
- Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformances, CAPAs, Change Control records and validations.
- May also support execution of these tasks
- Supports Continual Improvement initiatives, programs and projects
- Ensures that changes that could potentially impact product quality are assessed according to procedures
- Ensures that deviations from established procedures are investigated and documented per procedures
- Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
- Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
- Alerts senior management of quality, compliance, supply and safety risks
- Represents the quality unit during audits and inspections as needed
- Supports internal/external audits and inspections as part of the audit/inspection management team as needed
- Completes required assigned training to permit execution of required tasks
- Ensure controlled documents for the area of responsibility that require periodic review have an active owner assigned.
- Ensure document periodic review activities are completed on time for documents owned by assigned areas of responsibility.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications:Doctorate degree
Master’s degree and 3 years of Quality experience
Bachelor’s degree and 5 years of Quality experience
Associate’s degree and 10 years of Quality experience
High school diploma / GED and 12 years of Quality experience
And previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.
- Educational background in Life Sciences or Engineering
- Project management skills
- Available for Non-Standard Shift (Third Shift)
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Collaborate and communicate with higher level outside resources.
- Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, validation, and process development.
- Strong communication (both written and oral), facilitation, and presentation skills in English/Spanish.
- Strong skill in working independently and to effectively interact with various levels.
- Ability to lead and influence staff outside own organization.
- Ability to empower staff and manage and distribute workloads.
- Able to manage performance issues and conflict
- Ability to provide direction and establish goals for individual staff members and work groups.
- Ability to evaluate documentation/ operations according to company and regulatory guidelines
- Ability to interact with regulatory agencies
Some of the vast rewards of working here
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.
- 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 Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
If 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.
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 requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.