Quality Assurance Specialist

Job Title: Quality Assurance Specialist
Location: Lititz, PA
Duration: 15 Months+
 
Job Summary:
The Quality Specialist II is responsible for supporting the completion of Product Review reports and conducting investigations related to quality observations or trends. This role also includes maintaining and updating Laboratory Information Management System (LIMS) Master Data and collaborating with various teams to ensure data accuracy and compliance with quality standards.
 
Key Responsibilities:

• Analyze and report observations or trends discovered during data review to Quality Management.
• Maintain quality metrics and contribute to management reviews and presentations.
• Ensure timely completion and proper documentation of Product Reviews in the document management system.
• Fulfill and process LIMS Master Data change requests from the Quality Control Laboratory.
• Review submitted Master Data for accuracy and provide feedback or corrections.
• Support continuous improvement initiatives and perform additional duties as assigned.

 
Qualifications:

• Bachelor’s Degree or higher in a scientific or related field is required.
• Minimum of 2 years of experience in Quality Control or Quality Assurance within Pharmaceutical, Medical Device, OTC Drug, and/or Cosmetic manufacturing is required.
• Strong analytical and problem-solving skills.
• Excellent communication, leadership, and multitasking abilities.
• Self-motivated and able to work independently.
• Proven ability to work effectively within cross-functional teams.