Collins Consulting, Inc. · 6 days ago
QA Specialist II - Audit Readiness
Worcester, MA
Full-time
Onsite
Mid Level
3+ years expCollins Consulting, Inc. is seeking a QA Specialist II - Audit Readiness to support the quality organization's audit readiness activities. This role involves managing audit readiness improvement actions and working closely with subject matter experts to ensure compliance and enhance continuous improvement.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
Supports activities and initiatives of the quality organization to implement and manage audit readiness activities
This role will manage audit readiness improvement actions with site owners and track to closure
These improvements will be related to the manufacture of biological bulk drug substances, the Quality Control laboratories, facilities and utilities as applicable
In addition to monitoring and tracking open action items, work closely with subject matter experts to understand risk level, timeline, manpower needed to complete action items
Provide support to the QA Compliance to help prepare for audits, support up-coming audits, update documentation as needed to enhance continuous improvement, etc
Monitor action item list to add new action items, classify actions into the appropriate focus area and remove action items no longer deemed necessary
Analyze data from multiple sources to identify common trends and identify areas for improvement
Support QA Compliance activities as needed (Risk Management, Quality Plans, Internal Auditing, etc.)
Qualification
Required
Bachelor degree in Science
3-5 years of GMP experience, preferably in biologics, audit experience beneficial
Effective verbal and written communication skills
Organized
Good Verbal/Written Skills
Lead Meetings
Monitor and track actions to closure
Company
Collins Consulting, Inc.
Collins Consulting brings over two decades of total talent solutions experience to meet your on-demand consulting needs.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase