QO DP Tech III

Pfizer; Kalamazoo (MI); On-site; USD 33,000 - 54,000; Full time

Job summary

Pfizer in Kalamazoo, MI seeks a Quality Assurance Drug Product Batch Record Review associate to evaluate clinical and commercial drug batches. You will ensure documents match specifications using sampling and SPC methods, and approve change controls as needed to maintain cGMP compliance.

You will work within a collaborative Quality Assurance Drug Product Batch Record Review team, contribute to audits, prepare documentation, and support inspections while driving continuous improvement and timely

Qualifications

• High School Diploma and 4+ years of pharmaceutical industry experience.
• Experience with quality administered systems (GxP, cGMP).
• Strong written and oral communication skills; ability to work in cross-functional teams.

Responsibilities

• Review and release manufacturing and packaging records to ensure compliance with Pfizer policy and cGMP.
• Contribute to change control activities to maintain configuration management.
• Assist in QA investigations, deviations, and CAPAs as needed.
• Support inspections and prepare audit documentation.
• Drive continuous quality improvements and real-time quality decisions.

Skills

GxP knowledge

cGMP

Quality Assurance

Auditing

Documentation

Communication

Education

High School Diploma

Tools

eQMS

gLIMS

SAP

PDOCs

LRT

Batch Tracker

Job description

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective Quality Assurance Drug Product Batch Record Review team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve change control activities to ensure compliance with configuration management policies.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Create, review and approve Good Manufacturing Practices {also cGMP} audit reports.
• Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP’s.
• Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and elevate issues with potential market or stability impact.
• Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
• Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
• Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
• Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.
• Lead/Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.
• Maintain SOPs/OJTs/etc. for Manufacturing and Packaging records.
• Work with Operations to correct and reduce errors through effective communication and continuous improvement initiatives.
• Serve as audit support SME as needed.
• Drive continuous improvement initiatives to support the overall attainment goal.
• Support IMEX initiatives within the team.
• Utilize appropriate systems to complete tasks (LRT, LIMs, SAP, PacOne, QTS, PDOCs, etc…).

Here Is What You Need (Minimum Requirements)

• Applicant must have a High School Diploma and 4+ years of experience
• Experience in pharmaceutical industry
• Experience in Quality administered systems
• Sound knowledge of current Good Manufacturing Practices {part of GxP}
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills

Bonus Points If You Have (Preferred Requirements)

• Experience at a manufacturing site
• Experience of writing and managing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
• Experience with the following systems: eQMS, gLIMS, SAP, PDOCs, LRT, Batch Tracker

Physical/Mental Requirements

• Office position with time in the production environment.
• Consistently produces quality work.
• Must be able to work in a team environment within own team and interdepartmental teams.
• Must work under short timelines while maintaining quality work.
• Must have strong written and oral communication skills.

Non-Standard Work Schedule, Travel, or Environment Requirements

• Flexible working hours (1st shift).
• Work Location Assignment: On Premise

Other Job Details

• Last day to apply: September 3rd, 2026.
• The salary for this position ranges from $23.64 to $39.39 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States – Michigan – Kalamazoo location.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

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