Overview
Quality Assurance Manager Jobs in Humble, TX at Radiomedix, Inc.
Full Job Description
Job Description
The Quality Assurance Manager is responsible for overseeing and directing quality assurance activities for RadioMedix’s Contract Manufacturing Facility, SPICA Center located 19705 Aldine Westfield Rd Humble, Texas 77338. This includes establishment of Quality processes for our internal manufacturing capabilities, oversight of external partners and management of ongoing manufacturing and lot release.
Duties and responsibilities
Duties and 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.
Qualifications
Bachelor’s degree in a science discipline or related field is preferred
Minimum of 6-10 years’ experience in a quality assurance role of increasing responsibility, CQA a plus
Higher level understanding of industry regulation 21CFR 211
Experience in Radioligand therapy preferred
Experience in supporting Quality Control partnerships
Advanced knowledge of manufacturing and analytical services in the pharma industry, radiotheranostic therapeutic knowledge preferred
Working knowledge of GMP international regulations and ICH guidelines
Strong problem-solving skills
Ability to work independently and effectively as a team member with multidisciplinary project
Attention to detail with the ability to perform critical review of various types of documents
Strong organizational and time management skills
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Title: Quality Assurance Manager
Company: Radiomedix, Inc.
Location: Humble, TX
Category:
