The primary responsibilities for this role will be the review and approval of Research protocols and reports intended to support IND. Documents will be reviewed for compliance to applicable GxP regulations, compliance to methods and protocols, verification of data presented in reports, and assurance of data integrity.
The secondary point of focus for this opportunity will be to support the implementation of new processes and procedures, including implementation of appropriate electronic Quality Management Systems (QMS) and maintenance of all QMS content and master files.
· Perform review and approval of Research protocols and reports intended to support the IND.
· Support implementation and management of Training system.
· Generate metrics at the required frequency which drive accountability and delivery of targets
· Support all activities related to Vendor Management Program.
· Provide support for document control system.
· Support continuous improvement of current systems, procedures and practices by constructively challenging the current state to ensure consistency across systems
· Revise Quality System procedures
· Perform other Quality System support activities as necessary
· BS Degree in Life Sciences
· 5-8 years of related experience
· Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
· Working knowledge of current Good Laboratory Practices (GLP – 21 CFR Part58), Good Manufacturing Practices (cGMP – 21 CFR Part 210/211), and Electronic Records; Electronic Signatures (21 CFR Part 11).
· Proficiency in the use of Microsoft Office, PowerPoint, electronic document and Training systems.
· Experience with management and implementation of e-Quality Systems.
· Presentation development and performance skills is a preferred
· Good verbal and written communication skills
· Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives
· Demonstrated organizational skills to managing multiple projects and priorities.
Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.