Hiring: Quality Control Scientist (Microbiology) I/II/II/Sr. Company: Bachem Location: Vista, CA Job Posted Time: 2026-09-10 13:12:44 Target Skills & Keywords : Microsoft Office, Risk Management, Root Cause Analysis About the job Experience: •3 years’ experience in the pharmaceutical, biotechnology, or related life sciences industry Required Skills: •Perform necessary environmental monitoring procedures to include water sampling, viable and non-viable air sampling and viable surface monitoring •General upkeep of microbiology laboratory including monitoring of temperatures for incubators and storage refrigerators •Perform necessary testing for approval of vendors and qualification of necessary media used in the microbiology laboratory •Maintain and support the cleaning verification program by performing Total Organic Carbon testing •Trend microbiology data and report to management and QA to ensure systems are within trend •Perform endotoxin testing for final lyophilized peptide products. The kinetic and gel clot method will both be employed •Write/revise standard operating procedures, and other related GMP documentation as related to the job function as necessary •Maintain GMP areas to ensure compliance for all requirements for control of materials. This includes cleanliness and organization Qualifications: •Bachelor’s degree in chemistry, microbiology or related field •Master’s degree in chemistry, microbiology or related field (preferred) •Minimum of 3 years’ experience in the pharmaceutical, biotechnology, or related life sciences industry •Strong hands-on experience with microbiological and analytical techniques/instruments including but not limited to: Total Organic Carbon (TOC),Endotoxin (LAL), Conductivity, Bioburden testing, and Microbial Identification (e.g., MALDI-TOF). •Proficiency in environmental monitoring (EM), cleanroom qualification, and data trending programs using tools such as MODA, LIMS, or equivalent. •In-depth understanding of ICH guidelines (Q1, Q5, Q7, Q9, Q10), USP , , , , and current FDA, EMA, and global regulatory expectations. •Operational familiarity with quality risk management, deviation/investigation processes (e.g., CAPA), and root cause analysis tools (e.g., Fishbone, 5 Whys). •Strong documentation practices in compliance with ALCOA+ principles and data integrity standards. •Demonstrated capacity to plan, organize, and prioritize multiple tasks while working independently or as part of a cross-functional team. •Demonstrated ability to communicate clearly and effectively across technical and non-technical teams, including presentation of findings to internal stakeholders and external regulators. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!