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Quality Assurance Inspector (Hauppauge)

Quality Assurance Inspector (Hauppauge)

ConfidentialHauppauge, NY, US
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Job Title : QA Inspector

Location : Hauppauge & Central Islip, NY

Job Type : Full-Time

Department : Quality Assurance

About the Company

We 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 more .

Position Summary

The 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 Responsibilities

  • Perform 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.

Qualifications

  • Bachelors degree in Pharmaceutical Sciences, Chemistry, Biology, or related discipline preferred.
  • Minimum of 13 years QA experience in pharmaceutical manufacturing (OSD, sterile, or packaging).
  • Strong knowledge of cGMP, FDA, and regulatory guidelines .
  • Experience 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 & Competencies

  • Knowledge 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 Offer

  • Competitive base salary
  • Comprehensive benefits package (Medical, Dental, Vision, 401(k) with match)
  • Paid Time Off (PTO), Holidays, and Sick Leave
  • Professional growth opportunities in a fast-growing pharmaceutical company

    • Equal Opportunity Employer : We value diversity and are committed to creating an inclusive environment for all employees.

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    Quality Assurance Inspector • Hauppauge, NY, US