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.

Responsibilities

• 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.

Education

• 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.

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.

Additional Information

• 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.