The Fountain Groups · 2 hours ago
QA Specialist II
Worcester, MA
Contract
Onsite
Mid Level
$41/hr - $46/hr
3+ years expThe Fountain Groups is a company seeking a QA Specialist II to support audit readiness activities within their quality organization. The role involves managing audit readiness improvement actions, collaborating with site owners, and providing support for QA compliance and audits.
Staffing & Recruiting
Hiring Manager
Maureen Fanning
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, Client 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 Discipline
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
The Fountain Groups
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase