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3 дня назад

Centralized Document Management Team (CDMT) Specialist (Pharmaceuticals)

68 600 - 114 300$
Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Centralized Document Management Team (CDMT) Specialist (Pharmaceuticals): Managing the full lifecycle of GMP documents in QualityDocs for Pfizer’s Kalamazoo manufacturing site with an accent on document governance, compliance, standardization, and migration. Focus on harmonizing documentation across API, Drug Product, Engineering, Maintenance and Utilities, and Quality Operations, supporting inspection readiness, and improving data-driven document workflows.

Location: On-premise at the Kalamazoo site in Kalamazoo, Michigan, United States. Office-based work includes periodic production-environment access and occasional evening or weekend support. Permanent U.S. work authorization is required; visa sponsorship is not available. Relocation assistance may be available based on business needs and eligibility.

Salary: $68,600–$114,300 annual base salary, plus eligibility for a 7.5% bonus target and comprehensive benefits.

Company

hirify.global is a global pharmaceutical company developing and manufacturing medicines and vaccines for patients worldwide.

What you will do

  • Author, review, approve, and manage SOPs, batch records, and other GMP documents in QualityDocs.
  • Coordinate document intake, change requests, stakeholder alignment, approvals, controlled printing, reconciliation, and retention.
  • Triage and prioritize centralized documentation work across manufacturing, engineering, utilities, and quality functions.
  • Support migration from legacy PDOCs processes to QualityDocs while maintaining accuracy, completeness, and compliance.
  • Prepare documents for audits and inspections, support CAPA actions, and act as a subject matter expert for document management processes.
  • Track documentation metrics, identify improvement opportunities, and develop training materials, SOPs, and job aids.

Requirements

  • Bachelor’s degree with any experience, or an Associate’s degree with 4 years of relevant experience, or a high school diploma with 6 years of relevant experience.
  • Working knowledge of quality assurance and quality control systems, GMP, cGMP, and ALCOA data integrity principles.
  • Proficiency with computer software and electronic document management systems.
  • Effective written and verbal communication skills with the ability to work across organizational levels.
  • Self-motivation, accountability, flexibility, and willingness to learn changing responsibilities.
  • Authorization to work permanently in the United States is required; U.S. work visa sponsorship is unavailable now and in the future.

Nice to have

  • Experience with QualityDocs, QTS, PDOCs, GMP documentation, change control, and record retention requirements.
  • Knowledge of API or Drug Product master record systems such as QPSNT or MBR.
  • Experience with document standardization, harmonization, implementation, or migration projects.
  • Proficiency in Word, Visio, Excel, Outlook, data analysis, and reporting.
  • Experience using generative AI tools such as ChatGPT or Microsoft Copilot with awareness of responsible AI practices.

Culture & Benefits

  • Collaborative, cross-functional team environment supporting a 24/7 manufacturing operation.
  • Work focused on patient safety, science-based quality, compliance, and continuous improvement.
  • 401(k) matching and additional retirement savings contributions.
  • Paid vacation, holidays, personal days, caregiver or parental leave, and medical leave.
  • Medical, prescription drug, dental, and vision coverage.

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