Rangam · 19 hours ago
RCI-ABBV-32196 QA Specialist QA Specialist (Audit/Compliance) (Biologics/Pharma/Biotech)
Rangam is seeking a QA Specialist to support audit readiness activities within the quality organization. The role involves managing audit readiness improvement actions, tracking them to closure, and providing support for audits and compliance activities related to biological drug substances.
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
Rangam
Rangam is a global, innovative, Total Talent management firm with the mission of accelerating meaningful employment for everyone! We are a minority-, woman-, and disability-owned firm with over 25 years of experience promoting sustainable and inclusive talent programs within our communities and employers.
H1B Sponsorship
Rangam has a track record of offering H1B sponsorships. Please note that this does not
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Trends of Total Sponsorships
2025 (10)
2024 (2)
2023 (4)
2022 (5)
2021 (4)
2020 (9)
Funding
Current Stage
Late StageCompany data provided by crunchbase