QA Specialist II

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. 1. Excellent keyboarding for document/data change-control management, quality intelligence management, and other compliance-related activities as needed using electronic systems.

This is a hybrid position, Tues/Wed/Thurs onsite.

Purpose

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.

Education and Training

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. Responsibilities and independence will increase as proficiency is demonstrated.

What are the top 3-5 skills, experience or education required for this position:

1. Excellent keyboarding for document/data change-control management, quality intelligence management, and other compliance-related activities as needed using electronic systems

2. Proficient with use of standard office computer applications, emphasis with data export tools and pivot tables

3. Proactive, communication and collaboration with Supervisor and Team members. Asks questions as necessary and escalates concerns to Supervisor.

4. Efficient work planning, self-checking, execution, and accountability without requiring excessive direction

5. Detailed in assessment, execution, verification, and administration of electronic document change control and quality intelligence; does not include scientific content review

The benefits that you are eligible for with Collins Consulting, Inc:

• 401(k)
• Medical, Dental and Vision Insurance
• Term Life Insurance
• Accidental Death and Dismemberment
• Long Term Disability