R&D Quality Procedures Coordinator Bio/Pharma AP8507162
12 Month Contract
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.
- 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
- 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
ADPI, LLC Premier IT Staffing Company dealing with LARGE Direct Clients Only.
Role: R&D Quality Procedures Coordinator Bio/Pharma AP8507162
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