What You Will AchieveThis 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.
QualificationsMust-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.
- undefined
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:
- Work Location Assignment: On Premise
- Last day to apply: August 14th
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.
Quality Assurance and Control
