Quality Assurance (QA) 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

• 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

Job Description

• 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

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.
• Enterprise-specific training will be provided on applicable processes, procedures, systems, and assigned document management responsibilities.

Benefits

• Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
• Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
• Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
• 401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.