Pfizer

Supply Operation Quality Associate

Posted Yesterday

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Shanghai, Shanghai Municipality, Shanghai, CHN

In-Office

Entry level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Reviews clinical and commercial drug batches, manufacturing and packaging records, deviations, investigations, change controls, and quality systems for cGMP compliance. Supports inspection readiness, regulatory and customer inspections, real-time compliance issue resolution, statistical process control, and quality risk management activities.

Summary Generated by Built In

Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.
What You Will Achieve
In this role, you will:

Evaluate and review clinical and commercial drug batches to ensure quality.
Ensure product and process documents meet established specifications through rigorous sampling and statistical process control.
Identify and address deviations from manufacturing and packaging standards.
Approve investigations and oversee change control activities to maintain compliance with configuration management policies.
Contribute to project tasks and milestones, organizing work to meet deadlines.
Learn and apply basic team effectiveness skills within the immediate work team.
Make decisions within limited options to resolve basic problems under supervisor's direction.
Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards.
Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems.
Assist manufacturing/packaging staff in real-time compliance error detection and resolution, and lead or participate in Quality Risk Management assessments.

Here Is What You Need (Minimum Requirements)

Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
Experience in the pharmaceutical industry and Quality administered systems
Sound knowledge of current Good Manufacturing Practices (part of GxP)
Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
Effective written and oral communication skills

Bonus Points If You Have (Preferred Requirements)

Experience at a manufacturing site.
Managing and writing deviations
Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
Strong problem-solving skills
Ability to work independently and as part of a team
Excellent time management and multitasking abilities
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control

Skills Required

Bachelor's degree with any years of experience
Associate's degree with 4 years of relevant experience
High school diploma or equivalent with 6 years of relevant experience
Experience in the pharmaceutical industry and quality administration systems
Knowledge of current Good Manufacturing Practices (cGMP) and GxP
Ability to work effectively in team and interdepartmental environments
Effective written and oral communication skills
Experience at a manufacturing site
Experience managing and writing deviations
Experience with production batch record review, ERP systems, non-conformance investigations, root cause analysis, and change control management
Strong problem-solving skills
Ability to work independently and as part of a team
Excellent time management and multitasking abilities
Experience using AI tools such as ChatGPT or Microsoft Copilot

What the Team is Saying

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.