Join Our Team at Ascend Advanced Therapies!

At Ascend Advanced Therapies, we are dedicated to advancing innovative therapies that have the potential to transform patients' lives. Our team works collaboratively in a quality-driven, highly regulated environment to support the development and manufacturing of advanced therapeutics.

We are seeking a Quality Assurance Validation Specialist to join our Quality Assurance team in Alachua, Florida. This position plays an important role in supporting validation and qualification activities across manufacturing, facilities, utilities, and laboratory equipment, helping ensure regulatory compliance, data integrity, and operational readiness.

 

Key Responsibilities

  • Provide Quality Assurance oversight and support for validation activities involving manufacturing operations, facilities, utilities, and QC equipment.

  • Review and approve validation lifecycle documentation, including user and functional requirements, design qualification, installation qualification, operational qualification, performance qualification, process validation, and factory/site acceptance testing.

  • Execute qualification and validation studies according to approved protocols and standard operating procedures (SOPs), ensuring accurate documentation of results.

  • Support commissioning, equipment qualification, process and analytical validation, facilities and utilities qualification, computer system validation (CSV), and risk management activities.

  • Perform data integrity risk assessments and support compliance with applicable data integrity requirements, 21 CFR Part 11, and EU Annex 11.

  • Maintain validation schedules and registers, including monitoring and periodic revalidation of equipment and processes.

  • Review validation deviations and assist with investigations involving equipment, facilities, and related systems.

  • Serve as a QA Validation subject matter expert in support of planned and unplanned changes through the change control process.

  • Support validation protocol activities associated with new construction and facility expansion projects.

  • Compile and review validation performance data and metrics.

  • Participate in regulatory inspections and client audits to support continued cGMP compliance.

  • Develop, review, and revise SOPs and work instructions.

  • Collaborate with contract manufacturing and testing organizations to resolve quality-related issues.

  • Identify opportunities for continuous improvement in validation processes and practices.

  • Perform other duties as assigned.

Qualifications & Experience

Education

  • Bachelor's degree in Life Sciences, Engineering, or a related technical discipline; or

  • Associate's degree with a minimum of two years of pharmaceutical quality experience.

Experience & Technical Skills

  • 2–4 years of validation and/or quality experience in a pharmaceutical or biotechnology cGMP-regulated environment.

  • Hands-on experience executing equipment validation and qualification protocols, including IQ/OQ/PQ.

  • Working knowledge of cGMP requirements, 21 CFR Part 11, EU Annex 11, and GAMP 5.

  • Strong technical writing, documentation, organizational, and attention-to-detail skills.

Preferred Qualifications

  • Experience working with biologics.

Physical & Work Requirements

  • Ability to perform light physical work, including lifting up to 20 pounds, standing, walking, stooping, and repetitive motions.

  • Ability to work in indoor and outdoor environments and wear appropriate personal protective equipment (PPE).

  • Potential exposure to chemicals, manufacturing materials, noise, and biological agents.

  • Ability to perform activities involving technical documentation, data analysis, measuring devices, and visual differentiation.

  • Approximately 10% travel may be required.