Katalyst CRO ยท 1 day ago
QA Specialist- Risk Management
Worcester, MA
Contract
Onsite
Mid Level
3+ years expKatalyst CRO is a company focused on quality risk management in the pharmaceutical industry, and they are seeking a QA Specialist to manage and implement quality risk management activities. The role involves collaborating with technical experts, monitoring risk management activities, and supporting QA compliance efforts.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
The primary responsibilities will be collaborating with technical experts to update risk management documentation and ensure timely periodic review of risk documents and assist in revision when appropriate
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 Client 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's degree in science
3-5 years of GMP experience, preferably in Biologics
Effective verbal and written communication skills
Preferred
risk management experience beneficial
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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