Job title:- Document Controller
Location: Andover, MA or Groton, CT
Duration:- 12 Months
Pay rate: $50/hr
POSITION SUMMARY
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 (Client Learning Academy) are critical to support integration activities.
PDM document integration activities
• Collaborate 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 content
• Revise SOPs for consistency with template
• QC of content and confirmation in target application
• Assist SOP & Training Administrators with document approval workflows and training course creation
• Generation of best practices and/or job aids, including transition to target application with meta data for mapping of content
• Additional duties relevant to the harmonization and integration may be requested
ORGANIZATIONAL RELATIONSHIPS
• Collaborate 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 EXPERIENCE
• BS 6+ years; MS 4+ years
TECHNICAL SKILLS REQUIREMENTS
Expertise in document management systems, administration of training systems, and project management.
PHYSICAL POSITION REQUIREMENTS
• Hybrid office position requires sitting and ability to travel to Client site (Andover, Groton). Flexible hours to accommodate eastern (primary) and western time zones.
