Quality Control Associate, Microbiology

JOHNSON SERVICE GROUP; Carlsbad (CA); On-site; USD 77,366,000 - 91,693,000; Full time

Job summary

Johnson Service Group is seeking a Quality Control Associate, Microbiology in Carlsbad, CA to support aseptic fill/finish operations, environmental monitoring and microbiological testing. The role emphasizes cGMP compliance, contamination control, and process validation within a biotech manufacturing setting.

The candidate will perform routine EM, SOP/QA document work, and participate in investigations and continuous improvement projects.

Qualifications

• Combination of undergraduate coursework and on-the-job experience in Microbiology or a related discipline.
• Minimum three years of experience in Quality Control and environmental monitoring of GMP facilities.
• Strong communication, integrity and ability to work independently.

Responsibilities

• Serve as SME for microbiological assays during audits, risk assessments, investigations, and client visits.
• Support assay transfer, qualification and validation activities for microbial-based assays or client methods.
• Draft, revise and review QC SOPs and assay qualification protocols and reports.
• Perform analysis on in-process samples, APIs, raw materials, and stability samples using established methods.
• Conduct routine environmental monitoring of GMP/GLP facilities for particulates and surface viables.
• Initiate and participate in environmental monitoring excursions investigations and impact assessments.
• Support gowning qualification program for manufacturing and QC personnel.
• Perform monitoring of lab water and gas systems; conduct endotoxin, bioburden, growth promotion testing.

Skills

Oral communication

Written communication

Problem solving

Documentation

Independent work

Education

Undergraduate coursework in Microbiology or related discipline

Tools

Microsoft Office

Quality software

21 CFR 11 applications

Job description

Johnson Service Group is looking to hire a Quality Control Associate, Microbiology for a biotech manufacturing company in Carlsbad, CA.

Pay range for this position is $27 - $32 per hour. Direct Hire | Onsite.

Summary

We are seeking a Microbiology Specialist to support aseptic fill/finish operations, environmental monitoring, gowning qualifications, and microbiological testing. The ideal candidate will have experience with cGMP, aseptic processing, contamination control, and process validation.

Duties and Responsibilities

• Serve as a subject matter expert (SME) for Microbiological assays and methods during internal/external audits, risk assessments, investigations, and client visits
• Supports assay transfer, qualification, and validation activities for microbial based assays or clients' specific methods
• Author, revise, and review Quality Control (QC) standard operating procedures (SOPs) and assay qualification protocols and reports
• Perform analysis on in-process samples, APIs, raw materials, and stability samples using existing methods
• Perform routine and non-routine environmental monitoring (EM) of GMP and GLP manufacturing facilities for total particulates, air viables, and surface viables.
• Initiate and participate in the investigation of environmental monitoring excursions and assesses potential impact on product quality
• Support a Gowning Qualification Program for all manufacturing and QC personnel
• Perform routine monitoring of pharmaceutical water and gas systems
• Perform Bioburden, Growth Promotion, Endotoxin, Gram Stain, Microscopy, TOC, Conductivity, and Nitrates testing
• Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities
• Assist in trending EM data and generate quarterly and yearly reports
• Participate in inspection readiness activities
• Interact closely with other departments to ensure efficient, compliant, and timely execution of project activities
• Provide assistance as needed to maintain a functioning QC Laboratory, including material ordering, inventory control, general housekeeping, and other duties
• Assist in investigation and review of GMP quality events, including but not limited to deviations, non-conformances, and audit findings
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a client driven focus
• Safely operate laboratory equipment in accordance to established practices and SOPs
• Assist in training of additional team members
• Under minimum supervision, support special projects as needed
• Operates to the highest ethical and moral standards.
• Adheres to quality standards set by regulations and Argonaut Manufacturing Services policies and procedures
• Communicates effectively with supervisors, staff, and clients
• Participate in projects within a team and as an individual
• Support continuous improvement projects related to QC
• Multi-task, prioritize workload, document properly and interpret data accurately
• Follow laboratory safety requirements to promote a safety-first culture

Education and Experience Requirements

• Combination of Undergraduate courses and on-the-job experience in Microbiology or a related discipline (e.g., biology, chemistry, or biological sciences)
• Minimum three (3) years' experience in Quality Control and environmental monitoring of GMP facilities
• High intelligence and problem-solving skills
• Excellent oral and written communication and listening skills
• High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
• Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business is preferred
• General knowledge of one or more of compendial methods such as: Bioburden, Endotoxin, Growth Promotion, Sterility, and other microbiological methods
• Knowledge in environmental excursion investigations, root cause analysis, out of specifications, and knowledge of cleanroom practices is preferred
• Direct experience with endotoxin, bioburden, and growth promotion methodologies.
• Experience in sterility testing is highly desired
• Experience with transfers and qualification/validations of large molecule focused analytical methods
• Must have experience with Microsoft Office applications
• Experience with quality software and 21 CFR 11 applications preferred

Equal Opportunity Employer

Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.