Validation Qualification Specialist

Warren, New Jersey

Join Our Team as a Validation Qualification Specialist!

Location: 100% Onsite, Warren, NJ

Work Schedule: Mon – Fri, Business Hours

Are you passionate about ensuring the quality and compliance of laboratory equipment and systems in the pharmaceutical industry? We’re seeking a dedicated Validation Qualification Specialist to join our team in Warren, NJ. In this role, you’ll play a vital part in implementing and maintaining the highest standards of equipment qualification and validation.

Key Responsibilities:

  • Develop Protocols: Create qualification protocols and associated reports to ensure equipment and systems compliance.
  • Execute Qualification Activities: Carry out equipment/systems qualification and validation protocols with precision and attention to detail.
  • Supervise Vendors: Oversee vendor activities related to qualification functions, ensuring adherence to standards.
  • Develop Procedures: Create written procedures for calibration and preventive maintenance to uphold equipment integrity.
  • Project Management: Manage projects within the functional area, including equipment/systems implementation projects.
  • Technical Support: Provide expert guidance on calibration and equipment qualification issues, ensuring smooth operations.
  • Compliance Maintenance: Maintain all qualified equipment/systems in compliance with policies, guidelines, and procedures.

Required Skills:

  • Technical Writing: Excellent technical writing skills for creating detailed qualification protocols and reports.
  • Critical Thinking: Strong critical thinking and problem-solving abilities to address complex issues.
  • Regulatory Knowledge: Knowledge of cGXP requirements, good documentation practices, and 21 CFR Part 11 compliance.
  • Qualification Expertise: Proficiency in laboratory equipment/systems qualification processes and execution.
  • Project Management: Ability to manage projects, including scheduling, procurement, and implementation.
  • Communication: Excellent communication and customer service skills to interact effectively with stakeholders.
  • Attention to Detail: Meticulous attention to detail to ensure accuracy and completeness in all tasks.

Ready to Make an Impact?
If you’re passionate about quality assurance and compliance in the pharmaceutical industry, we want to hear from you! Apply now to join our team and contribute to the advancement of medical research and development.

About SSi People: 
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well. 

 

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