Centralized Document Management Team (CDMT) Specialist (Pharmaceuticals)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
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
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.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →