What are the responsibilities and job description for the Analyst 2 - Quality Systems Document position at Sunrise Systems Inc?
Job Title : Quality Systems Document Analyst 2 / Quality Document Specialist
Job ID : 25-06102
Location : Remote (EST)
Duration : 12 month's Contract on W2
Notes from HM :
- Role can be fully remote, would prefer to be Eastern time zone
- Possible titles could be Document Control Associate or Quality Document Specialist
- Bachelors degree not required, at least an Associates degree is REQUIRED
- Will help process and manage documents
- Creating document routing, and adding approvers
- Must have electronic document experience
- Will be formatting documents and checking them in
- Exp with EDMS
- Exp with Word and working with Tables
- Exp with Veeva (TruVault)
- Must have at least 5 years of experience
- CAPA experience can help, not required
Top 3 Skills :
Overview :
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).
The role will assist in the following tasks :
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
This position is also responsible for ensuring that SA / MA procedural documents are consistent and aligned with Pharmaceutical global processes, including but not limited to Pharmaceutical Enterprise Quality Standards, Cross Sector Documents, Commercial Quality Documents, Pharmaceutical Guidance Documents, HCC, Cross-Pharma, and Global Medical Organization documents.
This is intended to be a general job description and should not be construed as all inclusive.
ESSENTIAL FUNCTIONS :
Procedural Document Management
Manage the review & approval cycle to ensure procedural documents meet established development timelines and facilitates periodic review per procedural lifecycle requirements.
Liaise with other Pharmaceutical organizations when SA / MA or NA CQ procedural documents have interdependencies with those groups.
Ensures alignment of Pharmaceutical 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 75%
Training / Compliance
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. 25%
Contact :
Sharath Babu : sharath.b@sunrisesys.com | (732) 313-0251 | URL : www.sunrisesys.com
