Senior Quality Control Analytical Specialist

2 weeks ago


Mountain View, California, United States ESR Healthcare Full time

Job Title: Senior Quality Control Analytical Specialist

Company: ESR Healthcare

Overview: At ESR Healthcare, we are dedicated to pioneering advancements in cell and gene therapy. As a prominent global contract development and manufacturing organization, we focus on the innovative potential of regenerative medicine, shaping the future of healthcare.

The Senior Quality Control Analytical Specialist is essential in ensuring the integrity of clinical and commercial production processes. This role involves supporting various quality assurance activities, including stability assessments and analytical testing, to uphold the highest quality standards for our products.

Key Responsibilities:

  • Execute all testing methodologies and protocols for cellular products with precision.
  • Oversee the maintenance, monitoring, and troubleshooting of laboratory equipment.
  • Provide training and mentorship to junior Quality Control Analytical Specialists.
  • Maintain comprehensive training documentation and manage records retention.
  • Conduct testing, documentation, and reporting of results in accordance with established guidelines.
  • Assist in the management of quality control materials and inventory.
  • Lead investigations into any non-conforming test outcomes.
  • Initiate and prepare deviation reports as necessary.
  • Document training and oversee the execution of shipping test samples.
  • Ensure all documentation complies with procedural requirements.
  • Facilitate the timely issuance of Certificates of Analysis.
  • Communicate effectively with colleagues, departments, and clients.
  • Manage and resolve quality-related issues proactively.
  • Participate in audits and inspections as required.
  • Collaborate effectively with internal and external teams to meet project timelines.
  • Perform additional tasks as assigned.

Qualifications:

  • Bachelor's degree in a scientific discipline or related field is required.
  • Master's degree is preferred.
  • Experience in a cGMP environment is essential.
  • 4-6 years of experience in a Quality Control laboratory setting.
  • Proficiency in Microsoft Office and Visio.
  • Excellent written and verbal communication skills.
  • Detail-oriented with the ability to work collaboratively in a team setting.

Physical Requirements:

  • Ability to work in a laboratory environment for extended periods.
  • Physically capable of performing tasks such as standing, walking, and bending.

Working Environment:

The Senior Quality Control Analytical Specialist may encounter various environmental factors and must be prepared to work flexible hours as required by the organization.

Note:

This job description is subject to modification at any time without prior notice.



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