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Pioneer Data Systems

Document Control Specialist / Pharma Industry

Pioneer Data Systems, Andover, Massachusetts, us, 01810


Our client, a world-leading Pharmaceutical Company in Andover, MA is currently looking for a Document Control Specialist to join their expanding team.

In order to make an application, simply read through the following job description and make sure to attach relevant documents.

Position Details:Job Title: Document Control Specialist / Pharma IndustryDuration: 12 months contract, extendable up to 36 monthsLocation: Andover, MA

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:Assist PDM Compliance Lead responsible for managing and delivering the harmonization and integration of documents acquired through acquisitions by applying document management and technical transfer business standards using appropriate document management systems and corporate training systems, perform QC of Standard Operating Procedures/Business Practices/Job Aids, assist with authoring/revising described documents to meet PDM quality standards.Knowledge of GLP/GCLP operations, regulatory requirements and familiarity of GDMS, Gnosis and administration of My Essential Learning (Pharmaceutical Learning Academy) are critical to support integration activities.

Position ResponsibilitiesPDM document integration activitiesCollaborate with colleagues across PDM regulated groups, as needed, to track and manage key deliverables.Manually transition documents to target application including meta data for mapping of contentRevise SOPs for consistency with templateQC of content and confirmation in target applicationAssist SOP & Training Administrators with document approval workflows and training course creationGeneration of best practices and/or job aids, including transition to target application with meta data for mapping of contentAdditional duties relevant to the harmonization and integration may be requested

Organizational RelationshipsCollaborate with PDM regulated colleagues from bioanalytical, systems, and compliance groups across Andover MA, Groton CT, and Bothell WA sites.

Interviews:Teams Meeting or Onsite

Education And ExperienceBS 6+ years; MS 4+ years

Technical Skills RequirementsExpertise in document management systems, administration of training systems, and project management.

Physical Position RequirementsHybrid office position requires sitting and ability to travel to Pharmaceutical site (Andover, Groton). Flexible hours to accommodate eastern (primary) and western time zones.

Minimum Education:BS 6+ years; MS 4+ years