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Quality Assurance Inspector

Confidential - Hauppauge, NY

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Job Description

Job Title: QA InspectorLocation: Hauppauge & Central Islip, NYJob Type: Full-TimeDepartment: Quality AssuranceAbout the CompanyWe are a leading generic pharmaceutical manufacturing company with state-of-the-art facilities in Hauppauge and Central Islip, NY. We are committed to producing high-quality medicines that meet regulatory standards and improve patient lives. We are currently expanding our teams across multiple departments, including Warehouse, Packaging, Manufacturing, QA Document Control, and morePosition SummaryThe QA Inspector is responsible for ensuring that products, processes, and documentation comply with current Good Manufacturing Practices (cGMP), company policies, and regulatory requirements. This role involves in-process checks, batch record review, and oversight of production activities to maintain the highest level of quality and compliance.Key ResponsibilitiesPerform in-process inspections in manufacturing, packaging, and warehouse areas to ensure compliance with cGMP.Review batch records, logbooks, and supporting documentation for accuracy and completeness.Verify line clearance, equipment cleanliness, and readiness prior to manufacturing and packaging operations.Conduct sampling of raw materials, in-process materials, and finished products as per SOPs.Monitor adherence to Standard Operating Procedures (SOPs), regulatory requirements, and internal quality policies.Document deviations, non-conformances, and report findings to QA management.Support investigations, CAPAs, and change controls as required.Ensure compliance with safety, sanitation, and quality standards throughout the facility.Provide guidance to production teams to maintain compliance during daily operations.Collaborate with cross-functional departments to resolve quality-related issues.QualificationsBachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or related discipline preferred.Minimum of 1-3 years QA experience in pharmaceutical manufacturing (OSD, sterile, or packaging).Strong knowledge of cGMP, FDA, and regulatory guidelinesExperience with documentation review and in-process quality inspections.Excellent attention to detail, organizational, and communication skills.Ability to work independently and collaboratively in a fast-paced environment.Skills & CompetenciesKnowledge of pharmaceutical production processes (Manufacturing, Packaging, Warehouse).Strong documentation and record-keeping abilities.Problem-solving and decision-making skills.Familiarity with QA Document Control processes.Ability to multitask and manage priorities.What We OfferCompetitive base salaryComprehensive benefits package (Medical, Dental, Vision, 401(k) with match)Paid Time Off (PTO), Holidays, and Sick LeaveProfessional growth opportunities in a fast-growing pharmaceutical companyEqual Opportunity Employer: We value diversity and are committed to creating an inclusive environment for all employees.

Created: 2025-10-02

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