RCI-ABBV-32196 QA Specialist QA Specialist (Audit/Compliance) (Biologics/Pharma/Biotech) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Rangam · 14 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.

ConsultingInformation TechnologySoftwareStaffing Agency
check
H1B Sponsor Likelynote
Hiring Manager
Sumit Rawat
linkedin

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

GMP experienceAudit experienceBachelor degree in ScienceOrganizedVerbal/Written SkillsLead MeetingsMonitorTrack actions

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

twittertwittertwitter
company-logo
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 guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (2)
2023 (4)
2022 (5)
2021 (4)
2020 (9)

Funding

Current Stage
Late Stage

Leadership Team

leader-logo
Nish Parikh
Co-founder & CEO
linkedin
leader-logo
Hetal Parikh
Co-Founder & President
linkedin
Company data provided by crunchbase