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Document Management Specialist

Thousand Oaks, CA
Top 3 Must Have Skill Sets:    

Minimum 3 years prior experience writing controlled process documentation in the bio/pharma or medical device industry (other regulated environments may be considered.

Minimum 3 years leading cross-functional teams/subject matter experts.

Advanced Word, Excel.


Description:

Can be remote after covid policy is lifted.
Minimum 3 years prior experience writing controlled process documentation in the bio/pharma or medical device industry (other regulated environments may be considered.

Minimum 3 years leading cross-functional teams/subject matter experts.

Advanced Word, Excel.

Document Management Specialist
The primary responsibilities of the Document Management Specialist may include but are not limited to the following:
• Development (creation of revision) of controlled documents such as Standard Operating Procedures, Work Instructions, Forms, guidance and related business process documentation to support regulatory and business requirements and the Research &Development (R&D) Quality Management System. This will require:
o Project management experience and the ability to work to tight timelines whilst maintaining quality and dealing with multiple projects
o Collaboration with subject matter experts and interpretation of their input
o Utilization of process models
o Compliance with internal procedures (eg, Style Guide)
o Strong attention to detail during writing, review, revision, formatting and Quality Control of documents and related information
o The ability to track progress and to provide regular status reports to achieve goals and meet deadlines
o Issue and conflict resolution
o Utilization of electronic document repository
o Advanced skills in Word and Excel.
o Knowledge of English grammar and ability to write clearly and concisely.
• Serving as a subject matter expert and point of contact for R&D Quality processes.

Preferred Experience: project managed/led a cross-functional team of subject matter experts to drive R&D Quality document processes including generation and management of Smartsheet, identifying Quality strategy, oversight of process modeling, and oversight/generation of process documentation. Knowledge of Quality Management Systems

Required Skills:
• (advanced) Word, MS Outlook, Excel, and electronic document management repositories. MS Project and Visio experience preferred.
• At least 3 years prior experience specifically as a technical/business writer for writing controlled process documentation (eg, SOPs, Work Instructions) in the bio/pharma or medical device industry (other regulated environments may be considered)
• Excellent verbal and written communication skills/writing skills; active listening skills; attention to detail. strong process/business writing skills
• Strong analytic/critical-thinking and decision making abilities
• Candidate should have critical thinking skills who is able to work independently with little direction.
• Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment
• Prior experience leading cross-functional team/subject matter experts.

"This posting is for Contingent Worker, not an FTE"
 

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