Centralized Document Management Team (CDMT) Specialist

Pfizer • Kalamazoo, MI

11d • Onsite

About The Position

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.

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
• 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.

Nice To Haves

• 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

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• Ensure documents are inspection-ready and traceable; act as SME during audits/inspections for document management processes; support related CAPA and audit actions.
• 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.

Benefits

• 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
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED