Quality Assurance, Associate

3 days ago

Chestnut Ridge, NY, United States Strides Pharma Inc. Full time
Position: Associate, Quality Assurance (Sampling)

Department: Quality Assurance

Position Summary

The Entry-Level Associate, Quality Assurance supports the sampling activities and shop floor quality operations at the Chestnut Ridge site.

Roles and Responsibilities

Raw Material Sampler Key Responsibilities:
  • Cleaning/Approving: Cleaning, approving and preparing the sampling room and utensils for raw material sampling according to established procedures.
  • Inspection of Materials: Visually inspecting raw materials and packaging components for any damage, defects, or non-conformities before and during sampling.
  • Sampling: Collecting samples of incoming raw materials and packaging components from various vendors, warehouses or storage locations according to established GMP (Good Manufacturing Practice) and quality control procedures.
  • Documentation and Labeling: Accurately labeling and documenting samples with all relevant information (e.g., lot number, including sample details, date, time, and any relevant observations) and maintaining thorough records of all sampling activities.
  • Sample Handling and Delivery: Ensuring samples are stored correctly and securely and maintaining their integrity until they are delivered to the appropriate laboratories for testing (e.g., microbiology, chemistry, packaging).
  • Testing: Submitting samples to the laboratory for testing and analysis, often coordinating with lab personnel.
  • Record Keeping: Maintaining detailed records of all sampling activities, including test results and any deviations or discrepancies.
  • Communication: Effectively communicating with warehouse, procurement, and laboratory teams to coordinate sampling schedules, report discrepancies, and ensure a smooth workflow.
  • Inventory Management: Assisting with inventory tracking and the organization of raw materials in storage areas.
  • Safety Compliance: Following all safety protocols and procedures to prevent contamination and ensure a safe working environment.
  • Maintaining a Clean Work Environment: Ensuring the cleanliness and hygiene of sampling areas and equipment, especially in controlled environments.
  • Calibration and Maintenance: Calibrating or verifying the calibration of sampling instruments and maintaining supplies as needed.
  • Troubleshooting and Problem-Solving: Identifying and reporting any quality variances or issues with incoming materials and assisting in investigations of raw material complaints.
  • Compliance: Adhering strictly to all relevant safety procedures, regulatory requirements (like GMP), and company procedures to prevent contamination and ensure accurate results
Education & Experience
  • Required Education: High school or Bachelor's degree in Pharmaceutical Sciences or a related field.
  • Experience: 1-3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable).
  • Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred.
Physical Requirements
  • On-site role at Pearl River, NY.
  • Standard work hours: 7 AM to 4 PM.
  • No travel required.
  • Able to lift 50 lbs.

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