My Shortlist

Your shortlisted jobs will appear here. To view your shortlist, please login or register

DATE ADDED: Thu 11/10/2018

R&D Quality Procedures Coordinator Bio/Pharma AP8507162

Boston, USA
APPLY NOW

COMPANY: ADPI LLC

Job Description

 

R&D Quality Procedures Coordinator Bio/Pharma AP8507162

12 Month Contract

Boston, MA

 

The R&D Quality Procedures Coordinator manages a key process (value stream) that assures R&D employees perform their work in a consistent high-quality manner.  This involves providing strong technical leadership to drive procedural document management. 


Principle Responsibilities

  • Facilitate the authoring of effective Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs) Manage the change request, deviation and periodic review processes of procedural documents 
  • Assist in the  assessment and implementation of Quality Standards in R&D
  • Assist in the implementation of external regulatory changes in the appropriate procedural documents
  • Assist R&D in effectively implementing and leveraging available Document Control tools (e.g. firstDoc, PleaseReview, DocuSign).  This will need to be achieved through coordinating activities with the centralized Quality Systems support team
  • Serves as a super user of the electronic tools and technologies supporting the R&D Quality System.
  • Facilitates document generation process in the document management system and supports processes involving controlled documents.
  • Collates, organizes and archives essential paper documentation and/or binders where needed
  • Converts paper documentation to electronic format where needed
  • Facilitates and tracks transfer of key documentation between quality units at different sites


Qualifications

  • 8+ years of hands-on experience in pharmaceutical/biotech industry

·        Experience working in R&D functions (Clinical, Regulatory, Pharmacovigilance, etc.)

·        Experience in Procedural Document Lifecycle Management within a R&D Quality Management System including document workflow utilizing a Controlled Document Management System

  • Experience working with geographically and culturally diverse teams
  • Ability to influence peers without positional authority
  • Strong facilitation, negotiating and presentation skills. Able to work with all levels in the organization
  • Able to work effectively across functional, divisional, site and Vendor (CRO) boundaries.
  • Able to work in ambiguous situations to identify and resolve complex problems
  • Demonstrated ability to be a trusted partner across Lines and through tiers of the organization.
  • Contributes to a learning environment by sharing knowledge and best practices within and across the organization
  • Proactively manages change by identifying opportunities and coaching self and others through the change

 

Company Description
ADPI, LLC Premier IT Staffing Company dealing with LARGE Direct Clients Only.


Role: R&D Quality Procedures Coordinator Bio/Pharma AP8507162
Job Type:
Location: Boston,

Apply for this job now.
APPLY NOW