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Katalyst HealthCares & Life Sciences ยท 2 days ago
QA Specialist
Boston, MA
Full-time
Onsite
Entry, Mid Level
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Responsibilities
Promote a quality mindset and quality excellence approach to all activities.
Continue support of continuous improvement culture and industrial excellence methodologies.
Support employees and respective departments in a clear approach, communication, and action.
Provide proactive communication to customers for timely issue escalation and resolution.
Follow up on issues to ensure timely completion.
Support cross-functional communication.
Support batch release of drug substance including documentation compilation.
Perform review of manufacturing batch records for completeness and compliance with cGMPs.
Provide on-the-floor support to Manufacturing.
Support SAP integration and master data migration for batch release activities.
Working knowledge and/or ownership of quality systems like Change Control, CAPAs, Deviations, Self-inspection auditing, QA reporting, and approval of GMP documentation.
Support GMP compliance and inspection readiness within the organization.
Assist in coordinating work for the QA Operations team to facilitate timely release of product lots.
Qualification
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Required
Bachelor of Science or Bachelor of Arts degree in a scientific discipline
Demonstrated experience in regulatory inspection activities
Ability to work on multiple projects on a tight timeline
Ability to prioritize and the flexibility to adapt to changing priorities
Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets
SAP knowledge
Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production, and QC
Preferred
Root cause analysis experience
Company
Katalyst HealthCares & Life Sciences
Katalyst Healthcares & Life Sciences offers data management, analysis, quality assurance, pharmacovigilance, and human resource services.
51-200 employees
H1B Sponsorship
Katalyst HealthCares & Life Sciences 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
Trends of Total Sponsorships
2023 (20)
2022 (46)
2021 (43)
2020 (53)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
Company data provided by crunchbase
