Centralized Document Management Team (CDMT) Specialist
Job Location:
Kalamazoo, MI - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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
Ensure documents are inspection-ready and traceable; act as SME during audits/inspections for document management processes; support related CAPA and audit actions.
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
Bachelors degree with any years of experience or an Associates 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 includingrisk 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:
Work Location Assignment:On Premise
Last day to apply: August 14th
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 providers 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.
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Quality Assurance and ControlRequired Experience:
IC
About Company
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