Senior Quality Assurance Specialist, Operations

Senior Quality Assurance Specialist, Operation Location: 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. Key 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 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 What We Offer In Return You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. 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. Employer's Rights This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. #J-18808-Ljbffr