Rangam · 10 hours ago
RCI-ABBV-32196 Quality Assurance Specialist (CMO/Audit/GMP/Inspection) (Pharma/Biotech/Biologics)
Worcester, MA
Contract
Onsite
Mid Level
$41/hr - $43/hr
3+ years expRangam is seeking a Quality Assurance Specialist to oversee regulatory inspection and audit readiness. The role involves managing audit readiness improvement actions and supporting compliance activities related to the manufacture of biological bulk drug substances.
ConsultingInformation TechnologySoftwareStaffing Agency
Hiring Manager
Sumit Rawat
Responsibilities
Oversee the regulatory inspection and audit readiness
Working with TPM (Third-party manufacturing)
Working with biologics and drug substances
Support to regulatory audit readiness
Manufacturing area exp is needed
Biologics experience is a plus
Readiness activities is plusA
Couple of years of experience in QA in manufacturing or science
The regulatory background will also work
GMP experience
Must have good communication skills (good verbal and written skills)
Looking for a Manufacturing QA background
This person will not be dealing with the Capa system But GMP background will be great
Working with different agencies (US FDA, Canada, Japan and such other global agencies)
Audit experience (improving in Sop, facilities-related)
Execute the existing plan, Audit readiness
Familiar with Biologics exposure (cell culture and bio burden filing)
PHD candidate will also work
Organized
Good Verbal/Written Skills
Lead Meetings
Monitor and track actions to closure
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
Oversee the regulatory inspection and audit readiness
Working with TPM (Third-party manufacturing)
Working with biologics and drug substances
Working exp in biologics, drug substance, aseptic, bioburden, EM, QC, etc
Support to regulatory audit readiness
Manufacturing area exp is needed
GMP experience
Must have good communication skills (good verbal and written skills)
Looking for a Manufacturing QA background
This person will not be dealing with the Capa system But GMP background will be great
Working with different agencies (US FDA, Canada, Japan and such other global agencies)
Audit experience (improving in Sop, facilities-related)
Execute the existing plan, Audit readiness
Familiar with Biologics exposure (cell culture and bio burden filing)
PHD candidate will also work
Organized
Good Verbal/Written Skills
Lead Meetings
Monitor and track actions to closure
Bachelor degree in Science
3-5 years of GMP experience, preferably in biologics, audit experience beneficial
Effective verbal and written communication skills
Preferred
Biologics experience is a plus
Readiness activities is plus
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.
501-1000 employees
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 StageLeadership Team
Nish Parikh
Co-founder & CEO
Hetal Parikh
Co-Founder & President
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