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.
Senior Associate QA PQA On the FloorLive
What you will do
Lets do this! Lets change the world! In this vital role, will be responsible for PQA On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff; and also provide coaching, guidance and direction to Manufacturing, Quality Control, & Facilities/Engineering staff regarding compliance and quality systems. This position works a shift 4 schedule, which is 3 days a week Saturday through Monday 12 hours per day 7am 7pm.
Responsibilities Include the Following:
- Provide 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.
- Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
- Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, Corrective Action/Preventative Actions (CAPA).
- Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
- Establish and enable LEAN practices.
- Lead all aspects of and provide guidance during on-the-floor analytical testing.
- Ensure that changes that could potentially impact product quality are assessed according to procedures.
- Ensure that deviations from established procedures are investigated and documented per procedures.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Alert senior management of quality, compliance, supply and safety risks.
- Complete required assigned training to permit execution of required tasks.
- Drive operational improvement initiatives, programs and projects.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The detail-oriented professional we seek is a problem solver, and strong communicator with these qualifications.
- High school diploma / GED and 8 years of Quality/Manufacturing experience OR
- Associates degree and 6 years of Quality/Manufacturing experience OR
- Bachelors degree and 2 years of Quality/Manufacturing experience OR
- Masters degree
- Bachelors Degree & 2 year of Quality/Manufacturing experience
- cGMP Experience
- Experience in general compendia testing
- Experience using LIMS and/or SmartLab
- Experience and knowledge of Data Integrity Requirements of QC Systems
- Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)
- Experience of collaboration within and across functional areas and outstanding customer service focus
- Excellent written and verbal communication skills
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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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
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.
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.