Rangam · 2 days ago
RCI-ABBV-31980 Quality Risk Management Specialist (ICH Q9/EU Annex 1/CAPA/Investigations) (Biologics/Pharma)
Worcester, MA
Contract
Hybrid
Mid Level
$42/hr - $43/hr
3+ years expRangam is seeking a Quality Risk Management Specialist to support the quality organization in managing quality risk management activities. The role involves documenting evaluations relevant to commercial product risk for biologic drug substances and collaborating with technical experts to update risk management documentation.
ConsultingInformation TechnologySoftwareStaffing Agency
Hiring Manager
Sumit Rawat
Responsibilities
Supports activities and initiatives of the quality organization to implement and manage the quality risk management activities as well as leading different QRM related job tasks
This role will document evaluations relevant to commercial product risk for biologic drug substances, general site risk, risk associated with cross contamination, facilities, utilities and equipment risk as relevant to assigned responsibilities
Provide project support to the Cross Functional Team and help to facilitate risk documentation as needed for projects related to risk, continuous improvement, or investigations
Monitor and track open action items from the quality risk management activities, ensure they are implemented as required
Monitor periodic review, obsolete documents as necessary, maintain risk documentation and updates as needed
Analyze data from multiple sources to identify common trends and identify areas for improvement
Prepare reports to document the outputs of risk management monitoring activities, if required
Escalate Risk- Use sound judgement to identify novel events, new risks or changes to the risk profile, make recommendations to escalate or provide rationale why escalation is not necessary
Support QA Compliance activities as needed (Investigations, audits, etc.)
Qualification
Required
Science related background
Background in GMP manufacturing
Experience in a QA role
Experience in Risk Management
Good Oral and written communication skills. Ability to work with cross-functional teams
Bachelor degree in Science
3-5 years of GMP experience, preferably in Biologics, risk management experience beneficial
Effective verbal and written communication skills
Preferred
Working knowledge of ICHQ9, and Annex 1 helpful
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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