What are the responsibilities and job description for the Document Control Specialist position at jnj?
Johnson & Johnson Family of Companies
Title: Document Control Specialist
Location: Remote
Duration: 1 year
Pay Rate: $26.92
Benefits on offer for this contract position: Health Insurance, Life insurance, 401K and Voluntary Benefits
Please note that this is a contract role providing services to the Johnson & Johnson Family of Companies through external staffing partners of Kelly OCG. If you are selected for this role, you will be employed by a contract staffing supplier and will not be a member of the Johnson & Johnson Family of Companies.
Summary:
This role will assist in managing the procedural documents lifecycle (i.e., policies, standard operating procedures, work instructions, manual, guidelines, and forms) for the Scientific Affairs (SA), US Medical Affairs (MA) and Regional Commercial Quality North America organization in the Electronic Document Management System (EDMS), truVault (Veeva Quality Docs). This position is also responsible for ensuring that SA/MA procedural documents are consistent and aligned with J&J global processes, including but not limited to J&J Enterprise Quality Standards, Cross Sector Documents, Commercial Quality Documents, J&J Guidance Documents, HCC, Cross-Pharma, and Global Medical Organization documents.
Responsibilities:
- Coordination and tracking of periodic reviews
- Revision and obsolescence of documents
- Impact assessment process management
- Contribution of training contents and audience identification for procedural documents
- Updates to the US CQ Quality Manual and related reference documents
- Procedural Document Management - 75%
- Manage the review & approval cycle to ensure procedural documents meet established development timelines and facilitates periodic review per procedural lifecycle requirements.
- Liaise with other J&J organizations when SA/MA or NA CQ procedural documents have interdependencies with those groups.
- Ensures alignment of J&J standards, policies and procedures across SA/MA and NA Regional procedural documents.
- Manages procedural documents in electronic document management system
- Reviews findings, and monitors compliance trends related to procedural documents and communicates compliance issues/concerns to department manager.
- Assists during the impact assessment review and documentation process
- Training/Compliance - 25%
- Assists in identification of procedural document training audience with functional area managers
- Collaborates with Process Owners, Subject Matter Experts, and Training Managers in the development and review of training content/materials.
- Develop procedural document metrics and monitor compliance.
Qualifications:
- Associates degree or higher is required
- A minimum of 5 years of experience quality document control or related roles is required, preferably within the pharmaceutical, biotechnology, or healthcare industries.
- Intermediate to Advanced experience with MS Office is required
- Experience in procedural document lifecycle management, including drafting, reviewing, revising, and ensuring compliance with regulatory standards.
- Strong knowledge of global compliance standards
- Hands-on experience with document control systems, including managing reviews, approvals, and periodic review processes.
- Experience with Veeva/truVault is highly preferred
Salary : $27
