Quality Assurance Manager

Location

Humble, TX | United States

Job description

Title: QA Manager

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

• Lead onsite FDA Inspections
• Supports the establishment, preparation, and communication of quality metrics for specific production line. Identifies and works with function areas as appropriate to facilitate improvements.
• Reviews and approves Product Complaints and Product Quality Reviews; tracks and trends product and line performance to drive quality improvements.
• Interacts and communicates with customers to assure expectations are established, agreed to, and achieved.
• Work to establish Quality Assurance processes/documents/systems for internal manufacturing
• Building impactful relationships and collaborations across the organization to achieve corporate goals
• Perform the Quality Assurance role for Ga68 Generator Production, Re186 therapy, and Ga68 PSMA diagnostic. Activities include, but are not necessarily limited to, review/approval of:
  • Review and approve critical compliance documents in support of GMP
  • Executed batch records for compliance
  • Review Certificate of Analyses against raw data and/or specifications for compliance
  • Review of deviations, non-conforming materials, out of trend/calibration and specification results and ensure appropriate investigation and product impact assessment are performed and closed
  • Review of stability report against protocol and raw data
  • Risk assessments associated with assigned projects
  • 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 RadioMedix Inspection Readiness Program
• Work on continuous improvements, knowledge management, and striving for operational excellence
• Quality review of regulatory filings in support of projects

Qualifications

• Bachelor's degree in a science discipline or related field is preferred
• Minimum of 8-10 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
• Experience in plant start up is highly desirable
• 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
• Superior project management and communication 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

Job tags

Salary