What are the responsibilities and job description for the Analyst 2 - Quality Systems Document position at Pioneer Data Systems?
Position Details :
Our client, a world-leading Pharmaceutical Company in Titusville, NJ is currently looking for an Document Control Specialist to join their expanding team.
Job Title : Document Control Specialist / Pharma Industry / REMOTE WORK
Duration : 12 months contract, extendable up to 24 months
Location : Remote Worker
Client Location : Titusville, NJ
Note :
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description : Notes :
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 :
Document Control experience
Expertise in MS Office (Intermediate especially with WORD)
Quality document experience
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 :
Define key accountabilities and / or activities. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. % OF TIME
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%
