QA Associate

2 weeks ago


Ronkonkoma, United States Spirit Pharmaceuticals LLC. Full time

Responsibilities include, but are not limited to the following:Performing line clearances on a timely basis.Monitoring of packaging/inspection operations for conformance to specifications and SOPs.Maintaining and monitoring of logs -recording required information neatly and accurately.Preparing written reports, recording all information accurately and at required intervals.Maintaining of house standards, comparison of products for physical aspects/appearance.Providing editorial support and proofreading of labeling components (new and revised) to ensure product labeling requirements.Preparing and revising SOPs, BPRs, and labels for drug products.Assisting in technical guidance for compliance with cGMP, for completion and approval of complaints and investigational reports.Responsible for conducting cGMP training and other job-specific training and maintaining logbooks.Issuing of Batch Production Records and reviewing the daily production data.Preparing and reviewing of validation protocol.Receiving, Inspecting/Sampling, and releasing bulk products and packaging components.Responsible for cleaning validation of packaging lines. RequirementsSkills and Abilities:Excellent organization skills and detail-oriented.Ability to manage multiple tasks and meet company deadlines.Proficient in Microsoft Word, Excel, PowerPoint; Microsoft Office Outlook.Must be able to follow exact instructions set by the FDA.Must be able to communicate efficiently and effectively.May be required to work at the last minute.Education Qualification and Experience Requirements:Qualification: Bachelor's in Science/MSExperience: Minimum 1 -2 Yrs. Industrial Experience in the related fieldPrevious experience and knowledge of Quality Assurance and Regulatory Affairs are required.Previous experience in packaging in the pharmaceutical industry is a major plus. Salary Description $16 to $20



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