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 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 (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. Salary Range $83,500.00 – $133,500.00 USD Annual Location USA, CA – San Diego (BDB) Equal Opportunity Employer Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. #J-18808-Ljbffr Becton Dickinson