Specialist PQA

Amgen•New Albany, OH

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll 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 Let’s do this. Let’s 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. We’re 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 you’re passionate about quality, thrive in building and improving systems, and want to be part of something new and impactful—this is your moment. In this role, you will focus on strengthening and executing core Quality Systems while supporting startup and operational readiness:

Requirements

Doctorate degree OR Master’s degree and 2 years of Quality experience OR Bachelor’s degree and 4 years of Quality experience OR Associate’s degree and 8 years Quality experience OR High school diploma / GED and 10 years Quality experience

Nice To Haves

Bachelor’s 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

Responsibilities

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.

Benefits

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
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

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