Associate QA - PQA on the floor (Nights)

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Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Associate QA - PQA on the floor (Nights)

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for Quality 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 a rare opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff.

Amgens Quality Assurance On-the-Floor Associate position is on D Shift -Schedule for this position will be a rotating night shift (D shift), with working five days for one week (M, Tu, F, Sa & Su) and two days the following week (W & Th), shift hours will be 7pm to 7am.

Responsibilities include the following:

• Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.

• Perform and document scheduled quality oversight activities.

• Perform, review and approval of electronic batch records, SOPs, minor deviations and associated documentation.

• Enable LEAN practices.

• Oversee and provide mentorship during on-the-floor analytical testing.

• 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.

• Alerts senior management of quality, compliance, supply and safety risks.

• Completes required assigned training to implement required tasks.

• Participate in operational improvement initiatives, programs and projects.

• Complies with safety guidelines, cGMPs and other applicable regulatory requirements at all times.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek is a hard worker with these qualifications.

Basic Qualifications:

• High school/GED + 2 years Quality or Manufacturing work experience OR

• Associates + 6 months Quality or Manufacturing work experience OR

• Bachelor's

Preferred Qualifications:

• Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies

• Previous QA oversight of manufacturing, analytical or engineering activities

• Experience in good documentation practices, system knowledge, quality management systems

• Demonstrated experience with electronic systems (CDOCs, Maximo, LIMS)

• Experience in managing multiple, competing priorities in a fast-paced environment

• GMP industry experience, such as Direct bulk drug substance, drug product, or medical devices

• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with capability to communicate and collaborate effectively with technical and senior management staff

• Ability to partake in solving sophisticated problems with partners and make scientific risk-based decisions

• Demonstrated proficiency using Excel, Word and Power Point.

• Validated ability to be flexible and adaptable to support business needs.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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

• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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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