What are the responsibilities and job description for the QC Microbiology Manager (San Diego Metropolitan Area, CA) position at CEDENT?
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
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.
- 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.
