Quality Assurance Specialist

7 days ago

Caldwell, United States LTS Lohmann Therapy Systems, Corp. Full time
About LTS Lohmann Therapy Systems, Corp.

LTS Lohmann Therapy Systems, Corp. is a leading Contract Development and Manufacturing Organization (CDMO) that partners with the pharmaceutical industry to deliver innovative oral, transdermal, and intradermal drug delivery systems.

We are committed to utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value, and improve patient outcomes.

Job Summary

We are seeking a detail-oriented Quality Assurance professional to join our dynamic Quality Assurance team as a Supplier Quality Specialist.

This is a full-time, on-site role that can be located in West St. Paul, MN or West Caldwell, NJ.

Key Responsibilities
  • Audit Support: Assist in the planning, coordination, and execution of customer and internal GMP audits.
  • Supplier Qualification: Support the qualification and reassessment of suppliers, ensuring they meet our rigorous standards.
  • Documentation: Maintain accurate and up-to-date documentation related to supplier quality, including audit reports, qualification records, and corrective action plans.
  • Supplier Performance Monitoring: Track and analyze supplier performance data to identify trends and areas for improvement.
  • Supplier Corrective Actions: Assist in the development and implementation of corrective action plans for suppliers who do not meet quality requirements.
  • Quality Systems: Contribute to the maintenance and continuous improvement of our supplier quality management system.
Requirements
  • Bachelor's degree in science or related field
  • 9+ years of experience in a Pharmaceutical or medical device environment, with at least 2 years in a QA/QC role
  • Strong attention to detail and organizational skills
  • Proficiency in Word, Excel, PowerPoint, and SAP
  • Knowledge of industry standards, cGMP's, and regulatory requirements
  • Excellent communication and interpersonal skills
We Offer
  • Competitive compensation and benefits package
  • Opportunities for professional growth and development
  • A collaborative and supportive work environment
  • The chance to contribute to improving patient lives

LTS Lohmann Therapy Systems, Corp. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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