QA Specialist

A biotechnology company in Massachusetts is looking to add a new Quality Assurance Specialist to join their growing team.Responsibilities:Assist in the development, implementation, and maintenance of the quality management system (QMS)Manage document control processes, including document creation, review, approval, distribution, and archivalMaintain and update quality documents, standard operating procedures (SOPs), and recordsCoordinate audit preparations and responses, ensuring timely closure of audit findingsInvestigate and assess non-conformances, deviations, and incidentsAssist in risk assessments and risk management activitiesIdentify and assess potential risks and recommend mitigation strategiesPrepare and maintain quality reports, metrics, and key performance indicators (KPIs)Perform other duties, as neededQualifications:Bachelor's Degree in Life Sciences, Scientific, and/or a related fieldExperience in Quality Assurance or Quality Control within the Pharmaceutical, Biotechnology, or Rare Disease industryStrong knowledge of Regulatory requirements (FDA, EMA, ICH) and quality standardsProficiency in Document Control and Quality Management systemsGreat interpersonal skillsExcellent communication skills (written and verbal)Desired Skills:Certification in Quality Assurance or related field

Created: 2025-01-25