Quality Assurance Engineer

Responsibilities: Provide day-to-day Quality support of the warehouse, manufacturing, packaging, and batch record review areas. id in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products. Maintain an effective and efficient quality management system throughout the company, including ensuring compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Part 210 and 211 requirements. uthor, review, and approve cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents. Responsible for opening change controls and initiating, maintaining, and reviewing specific procedures relative to warehouse, manufacturing, and packaging. Identify non-compliance problems and propose solutions as appropriate. Effectively interact with other functional personnel at the site and corporate level and resolve quality related issues. Maintain knowledge of current regulations and quality policies. Attend quality-related meetings and conference calls. Interface with members of quality compliance and assurance team on quality related issues. Requirements: 5+ years of work experience in Quality Assurance or Regulatory Affairs in a cGMP pharmaceutical and/or biological manufacturing regulated environment preferred. Experience in a FDA regulated environment is required Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision required. Must have technical knowledge on the use of QMS systems (Documents, Training, Deviation, Change Control, CAPA) Excellent English writing, spelling, punctuation, and grammar skills. Strong interpersonal skills and the ability to effectively work and communicate with cross- functional teams. Self-motivated, work well independently and as a team player. Strong organizational and multitasking abilities Microsoft Office proficiency is required. Strong attention to detail. bility to lift 20 pounds Bachelor's degree SQ, CQE, CQA certifications a plus