Senior Quality Assurance Specialist, Operations

Job Title and Location Senior Quality Assurance Specialist, Ft. Worth, TX / Dallas, TX (Hybrid) Job Description 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. Responsibilities 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 is 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 based on severity. Works closely with others in the area to recognize opportunities for improvement and drives change through 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 backup for other personnel within QA. Other duties may be assigned. 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. Benefits You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities, and career advancement and cross‑training. Legal In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. The employer has the right to revise this job description at any time, and this job description is not an employment contract; either you or the employer may terminate employment at any time, for any reason. #J-18808-Ljbffr Galderma Laboratories, LP