Quality Control Scientist (Microbiology) I/II/II/Sr.

Bachem AG•Vista, CA

3d•$30 - $72•Onsite

About The Position

The Quality Control Scientist (Microbiology) will manage and execute the environmental monitoring program, water and critical utilities monitoring program. Other duties include performing, QC documentation including lab notebooks and reports and related GMP activities.

Requirements

Bachelor’s degree in chemistry, microbiology or related field
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 <61>, <62>, <85>, <1116>, and current FDA, EMA, and global regulatory expectations.
Experience working in classified cleanroom environments (ISO 7 and ISO 8) and aseptic processing operations.
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.
Ability 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.
Proficient in Microsoft Office Suite, with added benefit of experience in electronic quality systems (e.g., TrackWise, MasterControl).

Nice To Haves

Master’s degree in chemistry, microbiology or related field
Willingness to work flexible hours, including occasional night shifts and weekends, based on operational needs.

Responsibilities

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
Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control
Operate, maintain and ensure calibration of equipment including, chart recorders, thermometers, analytical balance, pipette and other related equipment in microbiology lab and the GMP facility as required by job function
Investigate any deviation or out of specification as necessary related to Quality Control work performed as instructed by supervisor
Follow safety guidelines for handling, disposal and use of chemicals and bacterial waste