Quality Assurance Analyst I

2 weeks ago


Salem, New Hampshire, United States Boston Analytical Full time
Position Overview

Salary: Competitive

JOB SUMMARY

The Quality Assurance Analyst plays a crucial role in supporting the QA Lead and ensuring the integrity of the company's quality management system by conducting audits of analytical data, routine tasks, protocols, and documentation.

KEY RESPONSIBILITIES

  • Assess and validate analytical data to ensure compliance with regulatory standards, company policies, and client specifications.
  • Serve as an alternate point of contact for inquiries related to QA processes in laboratory settings and client communications.
  • Evaluate laboratory protocols and reports for precision and adherence to current Good Manufacturing Practices (cGMP).
  • Confirm that data for Good Manufacturing Practice (GMP) materials, including raw materials, in-process samples, finished products, packaging, labeling, and manufacturing components, has been reviewed and sanctioned by the relevant Subject Matter Experts (SMEs).
  • Review and endorse documents and data linked to the Stability Program.
  • Undertake additional responsibilities as assigned by the Quality Assurance Lead.

QUALIFICATIONS & REQUIREMENTS

Applicants should possess a Bachelor's degree in a relevant scientific field, with 0-3 years of experience in Quality Assurance, ideally within the pharmaceutical sector.

ESSENTIAL SKILLS

  • Comprehensive understanding of GMP compliance regulations and guidelines is essential.
  • Ability to competently and safely execute the detailed responsibilities outlined above.
  • A proactive and motivated individual with strong interpersonal skills, capable of effectively collaborating with various departments and client representatives.
  • Excellent organizational, analytical, verbal communication, and technical writing skills are required.
  • Proficiency in computer applications, particularly MS Office software.
  • A collaborative team player with a commitment to the quality of products, services, and team members.


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