Scalence L.L.C. · 10 hours ago
QA Specialist- Audit Readiness
Worcester, MA
Full-time
Onsite
Mid Level
$40/hr - $42/hr
3+ years expScalence L.L.C. is a company focused on quality management in the pharmaceutical sector, and they are seeking a QA Specialist to manage audit readiness activities. This role involves monitoring and tracking actions related to the manufacture of biological bulk drug substances and supporting compliance with quality audits.
Information Technology & Services
Responsibilities
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
3-5 years of GMP experience, preferably in biologics, audit experience beneficial
Effective verbal and written communication skills
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase