Quality Specialist

Join our quality control team in an entry-level capacity focused on ensuring the integrity of our packaging materials. In this role, you will perform routine laboratory testing on incoming components- such as HDPE bottles, foils, films, and plastic caps- to maintain strict compliance and quality standards. Working in a collaborative team environment, you will operate precision analytical equipment, record critical quality data in laboratory systems, assist with investigations and root-cause analyses, and participate in daily operational tier meetings.

• Perform routine laboratory testing on incoming components, including HDPE bottles, foils, films, and plastic caps.
• Operate and maintain analytical testing equipment such as calipers, Magna Mike, FTIR, table-top scribers, and balances.
• Log test results, sample information, and technical data accurately into Labware and enterprise systems.
• Participate in investigations and root-cause analysis sessions for quality notifications and non-conformances.
• Assist with basic troubleshooting of laboratory instrumentation issues as needed.
• Engage actively in daily tier meetings and uphold a strong team-oriented mindset.
• Apply Good Manufacturing Practice (GMP) standards to complete thorough, compliant documentation and assist with updating operational procedures.

• B.A. or B.S. degree in Science or Engineering; OR
• Associate degree with 3+ years of pharmaceutical industry experience; OR
• High School Diploma / GED with 5+ years of pharmaceutical industry experience.

• Required:
  
  Ability to quickly learn and execute new processes, procedures, and component testing/review methodologies.
• Preferred: 1 year of experience in the pharmaceutical industry.
• Preferred:
  Hands-on experience using FTIR, calipers, table-top scribers, and applying ANSI sampling plans.
• Preferred:
  Technical proficiency with software systems, including SAP and GLIMS/Labware.
• Preferred:
  Strong technical writing skills (for revising procedures and writing quality notifications) and exposure to internal or regulatory agency audit environments.

• Role Level: Entry-Level position.
• Compliance Standards:
  Strong knowledge and application of GMP documentation guidelines required.
• Culture:
  Emphasizes continuous operational efficiency through daily tier process participation and cross-functional team collaboration.