QA Documentation & Change Control Specialist

Synectics Inc.; North Chicago (IL); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Healthcare Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Job summary

Synectics Inc. in Illinois seeks an individual contributor in R&D Scientific Compliance to coordinate and execute document change control within a GxP-regulated biopharmaceutical environment, collaborating with QA Documentation Management and R&D functions in a comfortable onsite office.

The role emphasizes meticulous document management, proactive communication with a supervisor and team, and hands-on use of electronic document management systems such as Veeva Vault and Microsoft 365 to support

Qualifications

• Preferred - Scientific degree or familiarity with general scientific terminology for pharma use
• Excellent keyboarding for document/data change-control management, quality intelligence management, and other compliance-related activities as needed using electronic systems
• Proficient with use of standard office computer applications, emphasis with data export tools and pivot tables
• Proactive, communication and collaboration with Supervisor and Team members
• Asks questions as necessary and escalates concerns to Supervisor
• Efficient work planning, self-checking, execution, and accountability without requiring excessive direction
• Detailed in assessment, execution, verification, and administration of electronic document change control and quality intelligence; does not include scientific content review
• Document management experience using an electronic document management system
• Highly preferred - Direct experience using an electronic document management system, e.g., Veeva Vault (One Vault) and Microsoft 365 applications
• Candidate will have good business communication skills, a solid knowledge of Microsoft 365 applications and prior experience with an electronic document management system
• Associate degree or higher required, with relevant experience in technical or business-oriented document management and electronic document management systems preferred.

Responsibilities

• Coordinate and execute document change control processing activities within a GxP-regulated biopharmaceutical R&D Compliance organization, collaborating with R&D Quality Assurance Documentation Management and R&D functional areas
• An individual contributor within an R&D Scientific Compliance group that supports a broad variety of topics and processes in a comfortable, collaborative onsite office setting

Education

Associate degree or higher

Scientific degree familiarity

Tools

Microsoft 365

Veeva Vault / One Vault

Electronic Document Management System

Pivot tables

Job description

Synectics Inc. in Illinois seeks an individual contributor in R&D Scientific Compliance to coordinate and execute document change control within a GxP-regulated biopharmaceutical environment, collaborating with QA Documentation Management and R&D functions in a comfortable onsite office.

The role emphasizes meticulous document management, proactive communication with a supervisor and team, and hands-on use of electronic document management systems such as Veeva Vault and Microsoft 365 to support