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10 дней назад

Quality Procedures & Training (QPT) Specialist (MasterControl)

Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
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
Quality Procedures & Training (QPT) Specialist (MasterControl): Administering controlled documents, training matrices, and compliance records in MasterControl and learning management systems with an accent on GxP requirements, ISO standards, and 21 CFR compliance. Focus on routing document changes, maintaining audit-ready records, coordinating regulated training workflows, and resolving document and training nonconformances.

Location: Hybrid role in Lake Forest, California, United States

Company

hirify.global operates a global quality and technical services organization supporting regulated documentation, training, and compliance activities.

What you will do

  • Administer Document Change Request routing and support the full lifecycle of controlled documents, from creation and review through release, periodic review, obsolescence, and archival.
  • Format, proofread, standardize, and maintain SOPs, work instructions, forms, policies, templates, whitepapers, metadata, attachments, and approval records.
  • Create and maintain courses, exams, job codes, trainee assignments, group sign-offs, training records, and role-based training matrices.
  • Monitor document and training compliance, prepare reports, investigate discrepancies, and support audits, inspections, CAPA, change control, and continuous improvement.
  • Guide document owners, approvers, managers, trainees, and administrators on MasterControl and Alchemy processes.
  • Train users on system navigation, document review and approval, DCR creation, and training completion while maintaining job aids and troubleshooting resources.

Requirements

  • Bachelor’s degree in science, engineering, quality, or a related technical discipline.
  • At least 3 years of hands-on experience in QA document control and training administration within a regulated environment.
  • Experience with document and training or learning management systems; MasterControl Documents and Training experience is strongly preferred.
  • Working knowledge of 21 CFR Parts 11, 111, and 117, as well as ISO/IEC 17025.
  • Advanced Microsoft Office skills, especially Word styles, multilevel numbering, document layout, templates, Excel tracking, and PowerPoint.
  • Strong organizational, analytical, written, verbal communication, and cross-functional coordination skills.

Culture & Benefits

  • Collaborative, deadline-driven work with Global Quality and Technical Services, functional managers, process owners, subject matter experts, HR, and regional administrators.
  • Work across worldwide operations with responsibility for clear communication, responsive service, and disciplined workflow coordination.
  • Eligible U.S. employees receive medical, dental, vision, HSA, FSA, life, disability, and employee assistance benefits.
  • Additional benefits include a 401(k), employee stock purchase plan, wellness incentives, supplemental insurance, and pet insurance.
  • Paid time off includes U.S. holidays, vacation, sick time, volunteer time, parental leave, bereavement leave, personal leave, and voting time.

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