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Radiomedix, Inc. · 1 month ago

Quality Assurance Associate Manager / Quality Assurance Manager

Humble, TX

Full-time

Onsite

Senior Level

6+ years exp

Radiomedix, Inc. is seeking a Quality Assurance Associate Manager / Quality Assurance Manager to oversee and direct quality assurance activities for their Contract Manufacturing Facility. The role involves establishing quality processes, managing compliance, and ensuring operational excellence in manufacturing.

BiotechnologyHealth Care

Responsibilities

Supports and/or lead onsite FDA Inspections and client audits

Identifies and works with functional areas as appropriate to facilitate operational improvements

Reviews and approves product complaints and Annual Product Quality Reviews; tracks and trends product and line performance to drive quality improvements

Interacts and communicates with clients to assure expectations are established, agreed to, and achieved

Works to establish Quality Assurance processes/documents/systems for manufacturing operations

Builds impactful relationships and collaborations across the organization to achieve corporate goals

Performs Quality Assurance activities including, but are not necessarily limited to, review/approval of:

Critical compliance documents in support of GMP

Executed batch records for compliance

Certificate of Analyses against raw data and/or specifications for compliance

Stability report against protocol and raw data

Release of RadioMedix owned raw materials, packaging components and products as needed

Review of project-specific procedures, protocols, and reports as needed

Support Quality Assurance Audits

Support and/or lead RadioMedix Inspection Readiness Program, including mitigation plans

Coaches and develops direct reports

Works on continuous improvement projects, knowledge management, and strive for operational excellence

Promotes and integrates quality into every aspect of our business

Establishes quality on the floor to assist and support the manufacturing team in detecting and solving compliance errors in real time

Quality review of regulatory filings in support of projects

Other duties as assigned

Qualification

Quality AssuranceGMP regulations21CFR 211CQA certificationRadioligand therapyAnalytical servicesProblem-solvingTeam collaborationAttention to detailOrganizational skillsTime management