Quality Specialist II

Job Responsibilities

• Execute stability studies for reagent products, including sample preparation, testing according to established protocols, and data collection.
• Perform various microbiological tests on raw materials, in-process samples, and finished goods, including but not limited to bioburden, sterility, and endotoxin testing.
• Analyze and interpret stability and microbiological test results, ensuring accuracy and adherence to specifications.
• Document all testing procedures, results, and observations in laboratory notebooks and designated quality management systems in a clear, concise, and timely manner.
• Identify and investigate out-of-specification (OOS) results, deviations, and non-conformances, documenting findings and participating in root cause analysis.
• Maintain and calibrate laboratory equipment, ensuring proper functioning and compliance with quality standards.
• Assist in the development and validation of new test methods and procedures for stability and microbiological testing.
• Contribute to the continuous improvement of quality control processes and procedures.
• Adhere to all safety regulations and good laboratory practices (GLP) and good manufacturing practices (GMP).
• Collaborate effectively with R&D, Manufacturing, and other Quality Assurance teams.

Required Qualifications

• Bachelor's degree in Microbiology, Biochemistry, Molecular Biology, or a related scientific field.
• 2-4 years of experience in a regulated laboratory environment, preferably in the pharmaceutical or biotechnology industry.
• Proven experience with reagent product stability testing and data analysis.
• Demonstrated expertise in a variety of microbiological testing techniques (e.g., bioburden, sterility, endotoxin, microbial identification).
• Strong understanding of GMP, GLP, and relevant regulatory requirements.
• Proficiency in laboratory instrumentation and data acquisition software.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team in a fast-paced environment.
• Strong attention to detail and organizational skills.
• Problem-solving skills and a proactive approach to quality issues.