QC Chemist II

About the Role

This position is responsible for analyzing drug substances, drug products, and stability samples using approved laboratory monographs, specifications, Standard Operating Procedures (SOPs), and USP/NF methodologies. The goal is to ensure all drug products manufactured and distributed by Pharmaceutical Associates, Inc. meet quality and compliance requirements.

Responsibilities

• Maintain cGMP/GDP awareness and compliance.
• Maintain laboratory housekeeping and clean glassware.
• Perform basic wet chemistry analysis, including:
  • Titrations
  • Identification tests
  • Impurity analysis
  • Residual solvents
• Provide in-process and final sample testing in support of production.
• Familiarity with compliance methodologies:
  • Laboratory monographs and specifications
  • Standard Operating Procedures (SOPs)
  • USP/NF
• Operate chromatographic instruments such as HPLC and GC.
• Execute Out-of-Specification (OOS) investigation plans.
• Perform technology transfers.
• Collaborate with key stakeholders within the department to meet shared goals and timelines.
• Use appropriate communication methods and tools, considering the recipient and intended audience.
• Train employees on fundamental knowledge, laboratory procedures, analytical test methods, and instrumentation as needed.
• Direct the work of technicians and/or temporary employees.
• Ensure tasks align with company policies and corporate values.
• Complete work in a timely, organized manner and admit mistakes while offering solutions to ensure compliance.
• Maintain a clean and safe working environment.
• Design tasks with efficient use of company resources in mind.
• Demonstrate tactical thinking and reasoning in completing assigned tasks.
• Show openness to new technologies, processes, and practices.
• Make recommendations for continuous improvement projects to enhance department methods, processes, and equipment.
• Apply problem-solving and decision-making skills to impact projects.

Requirements

• Bachelor of Science degree in a relevant field.
• Minimum of 2 years of experience.

To perform this job successfully, an individual must be able to satisfactorily perform the essential job functions.