Overview
Quality Assurance Manager Jobs in Humble, Texas, USA at Radiomedix, Inc.
The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.
QA Manager
Job Description
The Quality Assurance Manager is responsible for overseeing and managing quality assurance activities for Radio Medix’s Contract Manufacturing Facility for both manufacturing sites, SPICA Center located at 19705 Aldine Westfield Rd Humble, Texas 77338, and Richmond manufacturing facility at 9701 Richmond Avenue, Houston, TX 77042. This includes the establishment of Quality processes for our manufacturing operations.
Duties and Responsibilities:
Supports and/or leads onsite FDA Inspections and client audits.
Identifies and works with functional areas as appropriate to facilitate operational improvements.
Review and approve product complaints and annual product quality reviews; track and trend product and line performance to drive quality improvements.
Interacts and communicates with clients to ensure expectations are established, agreed to, and achieved.
Works to establish quality assurance processes, documents, and systems for manufacturing operations.
Builds impactful relationships and collaborations across the organization to achieve corporate goals.
Performs Quality Assurance activities including, but 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 Radio Medix-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 Radio Medix Inspection Readiness Program including mitigation plans.
Coaches and develops direct reports.
Works on continuous improvement projects, knowledge management, and strives 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 21
CFR 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 projects.
Attention to detail with the ability to perform critical review of various types of documents.
Strong organizational and time management skills.
Working Conditions:
This job operates in an office setting between SPICA and Richmond manufacturing facilities.
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Quality Assurance
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Title: Quality Assurance Manager
Company: Radiomedix, Inc.
Location: Humble, Texas, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, QA Specialist / Manager, Quality Engineering, Quality Technician/ Inspector)
