Quality Assurance Specialist

Title: Senior Quality Assurance Specialist – Operations (JR017286)Location: Fort Worth, TX or Dallas, TX IMPORTANT: Specific Job Role Requirements: 1. Serve as the primary TrackWise SME for Operations investigations, deviations, and CAPAs. Lead end-to-end quality investigations (deviations, complaints, distribution events), ensuring timely, thorough, and compliant root cause analysis. 2. Act as the Quality point of contact for distribution complaints and issue resolution involving CMOs and Logistics Service Providers. 3. Continuous improvement projects - Yellow Belt or higher certification desired. Job Summary The QA Specialist works independently to provide quality assurance oversight of any area assigned where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) including critical utilities, (e.g. Automation, equipment, HVAC, etc.), warehouse, distribution processes, inspection, labeling and packaging, batch disposition, new product introduction. Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to processes, risk management, and ensuring documentation and investigations meet all requirements. Key Responsibilities (100%) • Responsible for the quality release process for finished product distribution, including visual inspection of the finished product for the US market. • Manages temperature monitoring program for the distribution center, cold storage area and shipment of finished products. • Works with manufacturing sites to resolve quality issues such as consumer complaints, shipping and/or product storage conditions. • Review and approve artwork and rework instructions to ensure cGMP requirements are met. • Participates in multifunctional project teams to support the introduction of new products and/or changes to current products to ensure compliance with Quality System requirements. • Participates in inspection readiness activities and significantly involved in inspections by regulatory agencies. • Provides guidance and control directives regarding remediation activities required to continue business operations. Resolves critical issues within the area assigned and may escalate to senior management team based on the severity of the problem. • Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of the monthly quality improvement meeting. May be asked to lead process improvement initiatives. May also attend, as a QA project team member to provide QA guidance and oversight to such improvements. • Acts as back up for other personnel within QA. • Other duties may be assigned. Skills & Qualifications • Bachelor's degree required • At least five to seven years of related experience in Quality Assurance within a regulated environment or transferrable industry experience. • Knowledge of applicable GXP regulations • Knowledge of auditing techniques • Working knowledge of applicable computer software • Good organization and communication skills • Ability to manage multiple tasks • Good writing skills