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We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
Manages pharmaceutical batch release activities, including electronic and manual batch record review, expiration-date verification, investigation closure, quality holds, and lot disposition. Coordinates with plant disciplines to release manufactured lots while ensuring compliance with GMP, GDP, safety procedures, and regulatory requirements. Requires sterile injectable experience, audit participation, strong technical communication, and proficiency with quality, project management, statistical, and manufacturing systems.
Summary Generated by Built In
Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
What You Will Achieve
In this role, you will:
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Work Location Assignment: On Premise
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
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
What You Will Achieve
In this role, you will:
- Ensure that the electronic Batch Record/manual batch record Audit items are complete / approved per applicable policy/procedure.
- Ensure Expiration Date of the product/batch as per Marketing authorization specified.
- Ensure that all investigations are closed and disposition against the specified batches.
- Responsible for tracking of Quality restrictions/holds.
- Ensure adherence to Safety Procedures/GMP & GDP Practices.
- Interface with necessary plant disciplines to facilitate the accumulation, review, correction, and release of manufactured lots.
- Participate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System Manual.
Here Is What You Need (Minimum Requirements)
- B.Pharma, M.Pharma or MSC with 8-10 years of experience in Manufacturing Quality/Quality Control/ Production or in Quality Assurance of a pharmaceutical manufacturing facility.
- Sterile injectable experience
- Fundamental knowledge of basic work routines and standards sufficient to operate within narrow boundaries. Advanced/well-developed skills and knowledge within a specific professional discipline involving the integration of theory and principles with organizational practices and precedents.
- Excellent technical writing, communication, and presentation skills
- Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
- Experience in preparing and participating in audits and inspections
Bonus Points If You Have (Preferred Requirements)
- Knowledge on SAP, gLIMS and AMPS.
- Strong analytical and problem-solving skills
- Ability to work independently and as part of a team
- Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
- Ability to adapt to changing priorities and manage multiple tasks simultaneously
- Experience in mentoring and training colleagues
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: On Premise
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
- B.Pharma, M.Pharma, or MSc degree
- 8–10 years of experience in manufacturing quality, quality control, production, or pharmaceutical manufacturing quality assurance
- Sterile injectable experience
- Advanced knowledge within a specific professional discipline and ability to apply organizational practices and precedents
- Excellent technical writing, communication, and presentation skills
- Proficiency in Microsoft Office, Microsoft Project, and statistical software
- Experience preparing for and participating in audits and inspections
- Knowledge of SAP, gLIMS, and AMPS
- Strong analytical and problem-solving skills
- Ability to work independently and as part of a team
- Strong interpersonal and organizational communication skills
- Ability to adapt to changing priorities and manage multiple tasks
- Experience mentoring and training colleagues
- Experience using generative AI tools such as ChatGPT or Microsoft Copilot, with understanding of responsible AI practices
What the Team is Saying
Daniel
Diagnostics Launch Lead
Anna
R&D Privacy Steward
Esteban
Specialist
Pfizer
Pfizer Compensation & Benefits Highlights
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Healthcare Strength — Health coverage is described as comprehensive across medical, dental, vision, and mental‑health support, with strong plan options and provider networks. Feedback suggests these programs are a clear standout within the total rewards package.
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Retirement Support — Retirement programs feature a 401(k) with company matching plus an additional company retirement contribution. Feedback suggests these elements are consistently highlighted as valuable components of overall compensation.
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Leave & Time Off Breadth — Paid vacation, holidays, and sick time are often characterized as generous, with some locations offering the ability to purchase additional vacation days. Feedback suggests this breadth contributes meaningfully to work‑life balance.
Pfizer Insights
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The Company
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.
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Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
Hudson Yards
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