Jobs · Quality Assurance · California

QC Stability Manager

Abzena · San Diego, CA · 2 wk ago
On-siteQuality AssuranceFull-time

About the role

The QC Stability Manager is responsible for ensuring product stability throughout the shelf life of the products under their purview. This includes monitoring and maintaining the quality standards, conducting stability studies, and ensuring compliance with regulatory requirements.

Responsibilities

  • Oversee stability testing protocols and ensure adherence to established timelines and procedures.
  • Develop and implement stability studies to ensure product quality and safety.
  • Monitor and analyze data from stability studies to identify trends and deviations from expected results.
  • Collaborate with cross-functional teams to resolve issues related to product stability and quality.
  • Prepare and present stability study reports to senior management and regulatory authorities as required.

Requirements

  • Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
  • Minimum 5 years of experience in a pharmaceutical or biotechnology environment, with at least 2 years in a stability testing role.
  • Experience with GLP/GLP-2 and GMP guidelines.
  • Strong analytical skills and ability to interpret complex data.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and manage multiple projects simultaneously.

Qualifications

  • Knowledge of various analytical techniques and equipment used in stability testing.
  • Experience with statistical software and data analysis tools.
  • Understanding of regulatory requirements and compliance processes.
  • Ability to work in a fast-paced, dynamic environment.

Skills

  • Strong problem-solving and critical thinking skills.
  • Effective time management and organizational skills.
  • Proficiency in Microsoft Office Suite.

Benefits

  • Comprehensive health insurance coverage.
  • Flexible work schedule options.
  • Professional development opportunities.
  • Employee discounts on company products.

Pay

$80,000 - $90,000 annually.

Schedule

Monday through Friday, 8:00 AM - 4:30 PM.

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