Specialist PQA

Career Category

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. 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.

Specialist PQA

What you will do

Lets do this. Lets change the world. Amgen is expanding and with that comes an exciting opportunity to help build and strengthen quality systems that will support the next generation of packaging operations.

Were seeking a QA Specialist to play a pivotal role in our B2 expansion supporting Commissioning & Qualification (C&Q) and New Product Introduction (NPI) while ensuring our quality systems are robust compliant and inspection-ready from day one.

If youre passionate about quality thrive in building and improving systems and want to be part of something new and impactfulthis is your moment.

In this role you will focus on strengthening and executing core Quality Systems while supporting startup and operational readiness:

• Provide QA support for Commissioning & Qualification (C&Q) activities including review/approval of protocols and reports
• Actively support New Product Introduction (NPI) to ensure quality requirements are embedded from early stages through commercialization
• Lead and support Quality Systems processes including:
  • Deviations
  • Product Disposition
  • CAPAs
  • Change Controls

• Ensure timely thorough and compliant investigations driving effective root cause analysis and sustainable solutions
• Support batch disposition activities in alignment with packaging operations and quality requirements
• Partner with cross-functional teams to ensure quality systems are effectively implemented during B2 startup and ramp-up
• Drive and contribute to Continuous Improvement (CI) initiatives to enhance quality system performance and efficiency
• Ensure that changes impacting product quality are appropriately assessed and implemented through Change Control processes
• Maintain inspection readiness and support internal/external audits and regulatory inspections
• Identify and escalate quality and compliance risks
• Collaborate closely with Packaging Engineering PD Supply Chain and QC to ensure seamless execution

Position will train on first shift and then move to a shift structure. Possible shifts are 12 hour am 12 hour pm second or third shift and/or one weekend day.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The quality assurance professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree

OR

Masters degree and 2 years of Quality experience

OR

Bachelors degree and 4 years of Quality experience

OR

Associates degree and 8 years Quality experience

OR

High school diploma / GED and 10 years Quality experience

Preferred Qualifications:

• Bachelors degree in Life Sciences Engineering or related field
• 3 years of experience in Quality Assurance within a GMP-regulated environment
• Strong experience in Quality Systems (deviations CAPA change control disposition)
• Experience supporting C&Q validation or startup activities highly preferred
• Experience with New Product Introduction (NPI) in a regulated environment is a strong plus
• Knowledge of cGMP and GDP requirements with packaging experience preferred
• Ability to work flexible shifts as operations ramp up
• Strong analytical problem-solving and organizational skills
• A proactive collaborative mindset with the ability to operate in a fast-paced evolving environment

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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

Salary Range