QC Analyst B7 II - USA

Title: QC Analyst
Location: Onsite, Durham, NC

Introduction

This position is responsible for overseeing quality control processes, including in-process, release, raw material, and stability samples, as well as associated document management and data collection. The role requires adherence to GMP requirements and effective communication with Quality management.

Required Skills & Qualifications

• High School degree with 6 years related experience in a GMP Quality Control Laboratory or Associate's degree with 4 years related experience in a GMP Quality Control Laboratory or Preferred, Bachelors' degree in a relevant scientific concentration plus 2 years related experience in a GMP Quality Control Laboratory.
• Possess a strong understanding of the requirements of sample receipt and inventory management in a GMP laboratory.
• Excellent oral and written communication skills with strong technical writing experience required.
• Able to work independently and effectively within the group, within Quality, and across the site.
• Prior work experience at client or in client's Industry.

Applicants must be able to work directly for Artech on W2.

Preferred Skills & Qualifications

• Experience with both paper-based and electronic laboratory information management systems.
• Familiarity with FDA/EMEA regulations.
• Experience in writing and revising SOPs and technical reports.

Day-to-Day Responsibilities

• Manage sample tracking and inventory system to track commercial and development samples.
• Generate sample submission forms for various testing facilities and process returned results.
• Follow/track international shipments and alert logistics group of any customs clearance issues.
• Inspect incoming sample shipments and take necessary actions if samples do not comply with SOPs.
• Review and evaluate temperature data reports from temperature monitoring devices included with sample shipments.
• Execute protocols to support network stability, qualified material programs, and pipeline product studies.
• Create and continuously improve sample management procedures and processes.
• Communicate with other departments and sites to address compliance issues and implement corrective actions.

Company Benefits & Culture

• Comprehensive health and wellness benefits.
• Opportunities for professional development and career growth.
• Supportive and collaborative work environment.

For immediate consideration please click APPLY to begin the screening process with Alex.