QC Microbiology Manager (San Diego Metropolitan Area, CA)

Cedent Consulting Inc.; California (MO); On-site; USD 75,000 - 115,000; Full time

Job summary

Join a forward-thinking company as a QC Microbiology Manager, where you'll lead a dedicated team in ensuring the highest quality standards in microbiological testing and environmental monitoring. This role involves collaborating across departments, managing investigations, and maintaining compliance with GMP regulations. You'll have the opportunity to shape quality practices and mentor associates while contributing to the success of groundbreaking biopharmaceuticals. If you're passionate about quality control and ready to make an impact, this is the perfect role for you!

Qualifications

• 5+ years in Quality Control, ideally in a GMP environment.
• 1-3 years of managerial experience in microbiology.
• Knowledge of cleanroom practices and environmental monitoring.

Responsibilities

• Manage microbiology team and ensure compliance with production needs.
• Conduct investigations of EM excursions and maintain lab efficiency.
• Generate trend reports and assist with regulatory inspections.

Skills

GMP Compliance

Environmental Monitoring

Root Cause Analysis

Communication Skills

Organizational Skills

Education

B.S. or higher degree in Biology

Degree in related Life Sciences

Tools

Laboratory Equipment

Particle Counters

Air Samplers

Microscopes

Job description

QC Microbiology Manager (San Diego Metropolitan Area, CA)

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
The Quality Control Manager oversees and manages a team of QC Microbiology Associates. The Quality Control Microbiology team performs Environmental Monitoring (EM) and Utility testing, in-process bioburden and endotoxin testing, and release microbiological testing. The Quality Control Manager is a Subject Matter Expert (SME) for compendial and rapid microbiology laboratory methods and is a decision maker for QC Microbiology.

Responsibilities

• Manage the daily routine tasks for the microbiology team by collaborating with quality, manufacturing, facilities, and other functions; informing the team of the production needs and scheduling accordingly.
• Initiate and participate in the investigations of EM excursions and assess any potential impact on product quality.
• Generate quarterly and yearly EM/Water trend reports.
• Represent the Microbiology Team and processes during client and regulatory inspections.
• Provide data for monthly site and quarterly global Quality Management Review (QMR).
• Perform and review routine monitoring of EM, pharmaceutical water, and gas systems.
• Perform and review bioburden and endotoxin testing.
• Complete analysis and data analysis of in-process samples, APIs, and stability samples using existing methods.
• Responsible for the training of the QC Microbiology Associates and manufacturing on microbiological methods.
• Author and review Quality Control standard operating procedures (SOPs) and assay qualifications. Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities.
• Interact closely with other departments to ensure efficient, compliant, and timely execution of lab activities.
• Maintain the functioning of QC Laboratory, including material ordering, inventory control, general housekeeping, and other duties.
• Assist and own investigations and review of GMP quality events, including but not limited to deviations, out of specification reports, and audit findings.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer-driven focus.
• Utilize laboratory equipment in accordance with established practices and safety standards.
• Operate to the highest ethical and moral standards.
• Adhere to quality standards set by regulations and Client’s policies, procedures, and mission.
• Communicate effectively with direct manager, colleagues, and subordinates.
• Perform performance review of reports and drive their development.
• Participate effectively as a team player in all aspects of Client business.

Qualifications

• B.S. or higher degree in Biology, or related Life Sciences degree.
• Minimum 5+ years of experience working in Quality preferably in a GMP environment.
• Minimum 1-3 years managerial experience.
• Minimum 2 years of experience in environmental monitoring of GMP facilities.
• Minimum 2 years of experience working in a GMP microbiology lab.
• Preferred knowledge in environmental excursion investigations, root cause analysis, and/or knowledge of cleanroom practices.
• Experience with one or more of the methods such as: bioburden, endotoxin, total organic carbon, conductivity, or Gram staining.
• Knowledge of and experience in GMP, following standard test methods, or willingness to become GMP proficient.
• Ability to gown for and work in a cleanroom environment.
• Ability to accurately and precisely document and record laboratory activities, results, and conclusions.
• Ability to use routine laboratory equipment including, but not limited to, particle counters, air samplers, microscopes, etc.
• Ability to work well under pressure, multi-task, and have good organizational and communication skills.