Why Patients Need You
Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will have a direct impact on patient care. Your focus and commitment will be essential in achieving project tasks and goals, fostering a collaborative environment for your colleagues. Your hard work and dedication will help Pfizer reach new milestones and make a significant impact on patients worldwide.
What You Will Achieve
This role is part of the Centralized Document Management Team (CDMT) responsible for end-to-end lifecycle management of GMP documents using QualityDocs, replacing legacy PDOCs processes. The CDMT serves as a centralized, cross-functional capability supporting the entire site including API, Drug Product, Engineering, Maintenance and Utilities (EMU), and Quality Operations (QO) at the Kalamazoo site. The incumbent ensures standardized document creation, governance, migration, and continuous improvement aligned with cGMP, data integrity, and Pfizer Human Performance standards. The role shifts documentation from transactional processing to a strategic, standardized, and data-driven capability supporting inspection readiness and operational efficiency.
This position resides in a team environment within the Centralized Document Management Team and regularly interfaces with colleagues across the Kalamazoo Site, including Document Governance, Quality Systems, GMP Training, Compliance, Operations, Engineering, and site leadership. The role also supports interactions with internal audit teams and external regulatory authorities during inspections.
How You Will Achieve It
Document Lifecycle Management (QualityDocs)
Author, review, and manage SOPs, Master Batch Records, Non-Master Records, and other GMP documents directly within QualityDocs, ensuring consistent application of templates, taxonomy, and metadata standards.
Intake change requests, draft documents, facilitate stakeholder alignment, and drive timely approvals through quality systems.
Perform controlled print and reconciliation activities in accordance with GMP documentation requirements, ensuring issued copies are accurate, accounted for, reconciled, and retained as required.
Change Control & Compliance
Serve as responsible reviewer/approver for document changes within GMP frameworks; provide change control guidance to originators.
Ensure compliance with cGMP, ALCOA data integrity principles, and site procedures across all documentation activities.
Centralized Intake, Prioritization & Delivery
Operate within the centralized intake model, triaging and prioritizing work across API, DP, EMU, QO and the rest of the site using standardized criteria (inspection readiness, supply impact, compliance risk).
Monitor workflows, manage queues, track due dates, escalate off-track work, and provide stakeholder visibility on workload and timelines.
Standardization, Harmonization & Document Strategy
Drive harmonization across functional areas — reducing duplication and variation; apply standard templates, language, and structure; support "write-once, reuse" principles.
Support site Document Governance forums with data, insights, and recommendations for simplification, reduction, and lifecycle optimization.
Migration & Transformation
Execute and support migration activities from PDOCs/legacy systems into QualityDocs, ensuring accuracy, completeness, and compliance during each migration wave.
Partner with CDMT leadership on resource planning and execution.
Inspection Readiness & Audit Support
Continuous Improvement, Metrics & Training
Track and trend documentation metrics (error categories, cycle times, throughput) and identify improvement opportunities.
Develop OJTs, SOPs, and job aids; train and mentor team members and stakeholders on documentation processes and QualityDocs.
Qualifications
Must-Have
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
Working knowledge of Quality Assurance/Quality Control systems and Good Manufacturing Practices (cGMP).
Demonstrated proficiency in applicable computer software and electronic document management systems.
Effective verbal and written communication skills and ability to interact across all organizational levels.
Self-motivated with demonstrated personal accountability, flexibility, and willingness to learn new and changing responsibilities.
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Nice-to-Have
Experience with electronic document management systems such as QualityDocs, QTS, and/or PDOCs.
Subject matter expertise in GMP documentation (SOPs, batch records, change control processes).
Knowledge of Record Retention requirements and familiarity with site SOPs.
Knowledge of API and/or Drug Product master record systems (QPSNT and/or MBR).
Experience in document standardization, harmonization, system implementation, or migration projects.
Strong analytical, critical thinking, and attention-to-detail skills.
High proficiency in Word, Visio, Excel, and Outlook.
Demonstrated ability to work both independently and collaboratively in a cross-functional team environment.
Demonstrated commitment to Pfizer Values (Customer Focus, Courage, Excellence, Equity, Joy).
Demonstrated ability to learn and master new applications software
Experience in conducting and documenting manufacturing incident or customer complaint investigations
Knowledge of regulatory requirements and quality standards in the pharmaceutical industry
Strong problem-solving skills and the ability to think critically
Ability to work independently and as part of a team
Excellent written and verbal communication skills
Proficiency in data analysis and reporting
Strong interpersonal skills and the ability to build effective working relationships
Adaptability and flexibility in a fast-paced environment
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
PHYSICAL/MENTAL REQUIREMENTS
Office-based position with periodic time in the production environment.
Extended periods of sitting and computer use.
Occasional lifting of up to 25 lbs.
Aseptic gowning training may be required for production-area work.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
On-premise work assignment at the Kalamazoo site.
Occasional weekend, or evening work may be required to support a 24/7 manufacturing operation, audits/inspections, or QualityDocs migration deployment activities.
Other Job Details:
The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. 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 does not apply to Tampa, FL or any location outside of the United States.
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 [email protected]. 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
