Quality Engineer
Mark Cuban Cost Plus Drug Company, PBC
MissionHires is seeking a Quality Engineer on behalf of a fast-growing online pharmacy company to support quality engineering, compliance, validation, supplier quality, and continuous improvement activities for MCCPDC manufacturing and wholesale distribution operations. This early-career role helps ensure adherence to site procedures, FDA requirements, state regulations, cGMP standards, and applicable sterile and non-sterile compounding requirements. How You'll Contribute Support Engineering, Production, and Supply Chain teams in maintaining compliance with laws and regulations governing manufacturing and wholesale operations. Assist with day-to-day quality and compliance activities, including deviation logging, initial complaint processing, CAPA tracking, and audit preparation. Execute and support engineering and validation activities under the direction of senior quality engineering staff. Review and help draft technical documentation, including SOPs, product specifications, batch records, and change controls. Support Quality Management System oversight for the ACE program and training verification activities. Gather, organize, and maintain documentation required to establish and manage approved suppliers. Collect, compile, and perform basic analysis of quality data, metrics, and trends. Maintain accurate, legible, complete, and cGMP-compliant records and documentation. Build effective working relationships with cross-functional teams. Participate in continuous improvement projects and assigned workstreams. Lead new projects and workstreams as required. What Makes You a Great Fit Bachelor's degree in Engineering, a life science discipline, or equivalent relevant experience; graduate degree preferred. 0–3 years of relevant quality or engineering experience in an FDA-regulated environment. Knowledge of FDA and USP requirements for sterile and non-sterile compounding. Basic understanding of aseptic filling, terminal sterilization, and pharmaceutical compounding concepts. Working knowledge of cGMP requirements, including USP , 21 CFR Part 211, and applicable regulatory guidelines. Computer literacy and familiarity with electronic Quality Management Systems (eQMS). Strong data analysis, critical-thinking, and decision-making skills. Working knowledge of audit processes and audit readiness activities. Ability to uphold high quality and compliance standards without compromising customer expectations or regulatory requirements. Excellent written and verbal communication skills. Ability to work effectively in a collaborative environment with guidance and direction. Project management proficiency and/or experience with Operational Excellence methodologies preferred. Applicable industry or professional certification preferred. Regular and predictable attendance. Must be authorized to work without employer sponsorship; relocation assistance is not available. #J-18808-Ljbffr
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