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The QA Coordinator will be key player in ensuring quality and regulatory documents are organized and stored in an efficient and effective manner. The ideal candidate will have experience in a regulated environment, writing and reviewing SOPs, maintaining/ managing document control systems, and general QA / QC experience. Working knowledge of quality management system (QMS) is required.
Key Responsibilities
-Create and maintain document filing and organizing systems
-Ensure proper organization and security of documents (paper and electronic)
-Prepare reports on quality management system performance
-Track due dates for deviations/ incidents, CAPA, customer complaints and OOS investigations
-Reviews internal audit reports
-Provide technical expertise to assist with continuous improvement initiatives and process development activities including development of quality assurance programs and SOPs, as directed
-Working along with other members of the QA team, develop and improve quality programs and processes
-Lead QA special projects and initiatives as needed
-Provide support during inspections and third-party audits as required.
-Contribute to overall Quality Department goals
-Other duties as assigned
Requirements
-Bachelors degree or higher in relevant science (Quality Assurance, Food Science, Pharmaceutical Science or related field)
-3-5 years quality management systems experience
-Experience with electronic quality management system software preferred
-Experience authoring and/or reviewing quality documents or records in a regulated environment
-Experience in third party audits
-Must demonstrate proficiency in and Microsoft Office Suite
-Highly organized and detail-oriented with strong follow-up skills to manage large volumes of documentation
-Excellent written and verbal communication skills
Transportation/Travel Information
- Public transportation is not available