Mindlance · 2 days ago
QA Specialist II
Worcester, MA
Full-time
Hybrid
Mid Level
3+ years expMindlance is a company that focuses on quality risk management in the pharmaceutical industry. They are seeking a QA Specialist II to support quality risk management activities and collaborate with technical experts to ensure the timely review and documentation of risk management processes.
Human Resources
Responsibilities
Support 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
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
Collaborate 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
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 degree in Science
3-5 years of GMP experience, preferably in Biologics, risk management experience beneficial
Effective verbal and written communication skills
Company
Mindlance
Mindlance is a Staffing and Recruiting company which provides multi-vertical staffing services
1001-5000 employees
H1B Sponsorship
Mindlance 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 (71)
2024 (53)
2023 (37)
2022 (72)
2021 (36)
2020 (40)
Funding
Current Stage
Late StageLeadership Team
R
Rajat Paul Dhall
Co-Founder & Managing Director
V
Vik Kalra
Co-Founder and Managing Director
Recent News
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