Title: Director of Quality Assurance

RadioMedix Inc., a Biotechnology Company headquartered at 9701 Richmond Ave Houston, Texas 77042, is seeking a Quality Assurance Director. The successful candidate will play a key role in conducting Quality Assurance review of all drug products on site. The focus of the position will be to focus on high-priority projects at RadioMedix that will be integral to upcoming clinical trials. This is a newly created position with potential for significant growth.

We’re a growing company and we continue to add talent from a variety of fields. RadioMedix seeks to hire highly motivated and forward-thinking professionals interested in nuclear medicine research and development and influencing change within the Nuclear Medicine landscape

Duties and Responsibilities:

• Manage quality oversight to ensure Good Manufacturing Practice (GMP) internally and at suppliers during the manufacturing, handling, and shipping of the Company’s products.
• Manage production batch records for final approval and product release.
• Review and approve other GMP documents including, but not limited to, manufacturing validation protocols and reports, and transportation studies.
• Lead and provide oversight for processing change control requests, nonconforming product dispositions, and CAPA investigations related to production.
• Work with various departments to plan and schedule Quality Control (QA) and Quality Assurance (QA) resources.
• Lead and provide oversight with respect to the proper administration and adherence of all policies and procedures to sustain a state of current Good Manufacturing Practices (cGMP) compliance at the Company.
• Active participant in GMP audits and inspection readiness activities to ensure Company is in a constant state of inspection readiness.
• Interact with government agencies during GMP inspections.
• Actively participate in continuous improvement activities with cross-functional teams.
• Pursue improvements in inspection techniques and key production metrics through the use of test method validations and statistical process monitoring.
• Manage supplier quality through continuous monitoring and continuous improvement activities with internal cross-functional teams and supplier teams.
• Direct and oversee the Calibration program.
• Lead Global alignment activities on Operations Quality topics.
• Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
• Support disposition of raw materials, drug substance, and drug product.
• Support Vendor Qualification

Minimum Qualification:

• BS or equivalent and a minimum of 10 years laboratory experience, or a Master's level degree and a minimum of 8 years experience in the pharmaceutical/biotech industry
• 10 years experience in Quality Assurance in a pharmaceutical/biologic firm, with a minimum of 4 years in a management role.

Work Environment:

• Location: RadioMedix Spica Center, 19705 Aldine Westfield Rd, Humble, TX
• Work Conditions:
  • The work environment consists of manufacturing, laboratory, and office spaces. The position will sometimes require more than forty hours of work per week. The position is paid as salary. The work period is typically an 8-hour shift between 8 AM and 5 PM, with breaks. However, the work schedule may require the employee to come in for second or third shift if needed.
  • Individuals in this position will be exposed to ionizing radiation; however, radiation safety training will be provided, and radiation monitoring is required and ongoing at the facilities. Any exposure will be within Federal and State limits. Individuals in this position are required to be able to function and maneuver within the work environment without placing self, product, or others at risk. The position requires physical strength and dexterity with the ability to climb on ladders and up on equipment for environmental service and maintenance responsibilities.
  • Benefits: Health, Dental & Vision Insurance (effective 1st day of following month after start date)

  • Employer pays 50% of Employees Insurance

  • Paid Holiday’s Off
  • New Year’s Day
  • Memorial Day
  • Independence Day
  • Labor Day
  • Thanksgiving Day
  • Day After Thanksgiving
  • ½ Day Christmas Eve
  • Christmas Day
  • ½ Day New Year’s Eve
  • 401K Available after 12 months
  • 3 Weeks PTO

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