Quality Specialist - I

Join our Quality Control team as an entry-level Quality Control Analyst dedicated to maintaining high standards of quality and compliance. In this role, you will perform routine laboratory testing on incoming components such as HDPE bottles, foils, films, and plastic caps to ensure they meet all technical and regulatory specifications. Working in a regulated GMP environment, you will operate various laboratory testing instruments, log results into electronic data management systems, participate in root cause investigations, and engage in daily tier meetings. We are seeking a proactive team player with strong attention to detail, good GMP documentation skills, and an eagerness to quickly learn new testing processes, equipment, and procedures.

Responsibilities

• Perform routine laboratory testing on incoming components, including HDPE bottles, foils, films, and plastic caps, ensuring strict adherence to procedures.
• Safely operate and maintain analytical testing equipment such as calipers, Magna Mike, FTIR, table-top scribers, and analytical balances.
• Accurately enter and manage analytical testing data within Labware LIMS and related software platforms.
• Maintain thorough, compliant, and timely documentation in accordance with Good Manufacturing Practice (GMP) guidelines.
• Participate actively in laboratory investigations, root cause analysis sessions, and Quality Notification write-ups.
• Perform basic, occasional troubleshooting on laboratory testing instrumentation as needed.
• Contribute to continuous improvement and operational alignment by participating in the daily tier meeting process.
• Apply ANSI sampling plans correctly to incoming materials and components to support release testing.
• Utilize technical writing skills to assist with updating and revising laboratory testing procedures.
• Collaborate effectively with cross-functional teams while maintaining a strong team-oriented mindset.

Education

• Bachelor’s Degree: B.A. or B.S. in Science or Engineering (0 years experience required); OR
• Associate Degree: Associate degree with a minimum of 3 years of pharmaceutical industry experience; OR
• High School Diploma: High School Diploma (or equivalent) with a minimum of 5 years of pharmaceutical industry experience.

Experience

• Required Skills:
• Ability to quickly learn and adopt new processes, testing procedures, and analytical laboratory equipment.
• Demonstrated understanding and application of GMP documentation practices.

Preferred Experience & Skills:

• 1 year of pharmaceutical industry experience.
• Experience using specialized testing tools and instruments, including calipers, table-top scribers, Magna Mike, and FTIR.
• Working knowledge of Labware GLIMS and SAP systems.
• Familiarity with ANSI sampling plans and their application.
• Strong technical writing skills for drafting or revising procedures and writing quality notifications.
• Exposure to internal or regulatory agency audit scenarios.

Additional Information

• Job Type: Full-Time / Entry-Level
• Work Environment: On-site Quality Control Laboratory / Pharmaceutical Manufacturing.