QC Microbiology Job Description
QC microbiology
provides guidance and training for Quality Control staff in the accomplishment of Quality Control operation activities including GMP/GLP.
QC Microbiology Duties & Responsibilities
To write an effective QC microbiology job description, begin by listing detailed duties, responsibilities and expectations. We have included QC microbiology job description templates that you can modify and use.
Sample responsibilities for this position include:
Test to a high, and continuously improving, level of GMP/GLP compliance to ensure patient safety and to minimize risk to the company business
Perform routine testing and basic GMP paperwork review with supervisor direction
Oversee the development and tracking to a plan for day-to-day testing activities to meet the daily manufacturing and batch disposition schedule while maintaining the highest levels of GMP compliance
Full responsibility for the operation of the laboratory
Frequently review staff training to ensure that that it meets the requirements of the laboratory and fulfil the needs and aspirations of the individual
Enhancements and improvements to current commercial processes
DCMC Team participation for establishment of sample points and limits/specifications for new products/interfacing with various R&D groups
Periodic review of microbial limits
Excursion and contamination response harmonization
Analyzes data and results and provides conclusions and proposals for future directions
QC Microbiology Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QC Microbiology
List any licenses or certifications required by the position: HR, ASCP
Education for QC Microbiology
Typically a job would require a certain level of education.
Employers hiring for the QC microbiology job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Microbiology, Science, Biology, Technical, Education, Biochemistry, Chemistry, Life Sciences, Associates, Biological Sciences
Skills for QC Microbiology
Desired skills for QC microbiology include:
CGMP
USP
LIMS
GLP
CFR
FDA regulations
Project management
GMP
SOPs and quality control processes
EP
Desired experience for QC microbiology includes:
Escalate issues professionally and on a timely basis* Decision Making skills
Minimum of four (4) years of relevant experience in a laboratory environment performing sterility testing, or equivalent
Minimum of five (5) years relevant experience in quality control
Minimum of one to three (1-3) years of leadership/supervisory experience in commercial operations
Experience with the execution and validation of microbiological test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing
Bachelors' Degree in Biology (Microbiology)
QC Microbiology Examples
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QC Microbiology Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of QC microbiology. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for QC microbiology
- Participate in and/or lead OOS and other quality investigations
- Overall responsibility for QC In process, Release and Stability testing and the associated test and laboratory documentation
- Supervision/Management of laboratory personnel and adjustments to schedules to maximise efficiencies and adequately support production and other departments
- Conduct performance appraisal reviews for laboratory colleagues and identify training requirements for further development of colleagues
- Excellent communication (written and oral) skills as an individual contributor
- Manage day to day activities in the lab across Microbiology functional groups
- Collect and process samples in a timely manner, review associated documentation for accuracy and timeliness, evaluate preliminary results
- Participate in investigations and other related studies
- Ensure the highest levels of safety and environmental compliance
- Develop a long-term capacity plan for the forecasted manufacturing schedule
Qualifications for QC microbiology
- Deepens technical knowledge through exposure and continuous learning
- Having experiences min
- Weekend job
- Requires Bachelor’s degree in Microbiology, Biotechnology, Molecular Biology, or related discipline and 10 years of experience working in microbiology in a pharmaceutical manufacturing environment with team leadership experience
- An equivalent combination of experience/education is acceptable
- Partners with IMF Department Managers & site leaders
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QC Microbiology Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of QC microbiology. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for QC microbiology
- Initiate OOS investigations for Final Product, In-Process, Stability and other cGMP data
- Develop and continually update the production schedule on a weekly, monthly and quarterly basis and ensure alignment/adjustment of manufacturing schedule to meet development program milestones and corporate goals, as appropriate
- Ensure that equipment and processes are appropriately maintained and approved for specified testing activities
- Build a world-class organization by recruiting and developing top talent
- Support strategic plans for laboratory, process, and plant continuous improvements in order to increase efficiency and drive down costs
- Author any required Quality Agreements with external laboratory partners
- Support implementation of any capital expenditures within established budget and timeline
- Support manufacturing schedules as required, for week-end and holiday support
- Perform laboratory investigations and generate reports in response to action / alert notifications, OOS or aberrant trends / results
- Maintain cleaning, maintenance, and filing systems within area of responsibility to ensure compliance and good lab practices
Qualifications for QC microbiology
- Supports Business Leaders
- Reports to Site Quality Director
- Experience of 3-5 years as a Technician is acceptable with High School diploma/GED
- This position is a day shift position working Sunday thru Thursday
- Maintain positive attitude in a team environment
- Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.• To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory
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QC Microbiology Job Description
Job Description Example
Our company is growing rapidly and is hiring for a QC microbiology. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for QC microbiology
- Train, coach, and mentor QC Microbiology personnel
- Write and review SOPs, protocols and reports for QC Microbiology
- Perform / manage / support special projects as assigned
- Providing strong, consistent leadership within the QC Microbiology laboratory
- Coordination and direction of activities of the microbiology laboratory to ensure streamlined and successful operations with minimal downtime
- Coordination of environmental and critical utility monitoring programs
- Providing technical expertise, knowledge and guidance to the QC Analysts
- Ensuring local and global KPI’s are consistently met and exceeded
- Supporting and implementing continuous improvement processes
- Management of relationships with key stakeholders
Qualifications for QC microbiology
- Fluent with FDA OOS Guidelines
- Knowledge of method development and validation
- Knowledge of industry microbiology practices
- Knowledge of cell culture practices
- Experience in method transfer
- Knowledge of virology testing
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QC Microbiology Job Description
Job Description Example
Our company is looking for a QC microbiology. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for QC microbiology
- Support activities to conduct and perform necessary sampling/test methods or compendia methods in the lab and site under cGMP
- Receive training and analyst qualification to perform sampling/testing under cGMP
- Review and approval of batch release testing documentation
- Ability to work under fluid and dynamic conditions
- Ability to work under tight deadlines with minimal supervision
- Excellent communication, problem solving and organisational skills
- A thorough understanding of pharmaceutical microbiology and sterility assurance is ideal
- Minimum a tertiary degree in Science Microbiology or related
- Reviews technical reports and other sources of information to ensure that laboratory practices are consistent with current industry and regulatory requirements
- Proficient in Microbial Identification methodology
Qualifications for QC microbiology
- Bachelor’s degree in Microbiology or Life Sciences with 3 - 5 years industry microbiology laboratory experience
- Knowledge of teamwork and coaching techniques
- Knowledge of on the job training techniques
- Knowledge of Microbiology as it applies to the biopharmaceutical industry is required
- This individual must be able to give clear instructions and to train individuals on practices within the QC Microbiology laboratory
- The manager is expected to possess the skills and knowledge required to technically train subordinates and assist in their career development
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QC Microbiology Job Description
Job Description Example
Our innovative and growing company is looking for a QC microbiology. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for QC microbiology
- Directs the work activities for team members to ensure that corporate, project, and departmental objectives are completed efficiently within defined timelines
- Implements plans and procedures to ensure work areas meet all company policies, standards for hygiene, safety and security and lab activities are conducted according to safety guidelines, policies and legislation
- Reviews and approves unit procedures relating to testing, sampling, or related operations
- Ensures the reliability and accuracy of the computer databases and paper files
- Investigates aberrant values and trends
- Assists with troubleshooting of test procedures
- Create/revise documents
- Perform process environmental monitoring (EM) during aseptic cleanroom filling operations
- Perform routine (EM) of fill rooms, ancillary room and compounding areas
- Perform General Microbiological Testing such as Bioburden, Endotoxin, sterile hold test, total plate count (TPC), Sterility testing, Coliform and biological indicator
Qualifications for QC microbiology
- A minimum of 7 years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required
- The ideal candidate is well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell therapy product
- The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, on an as-needed
- Requires BA/BS in microbiology or closely related field with at least 7 years’ experience in a microbiology lab, preferably in the pharmaceutical or biotech industry
- Relevant degree qualification in technical/scientific disciplines Pharmacy, Pharmaceutical Chemistry, more preferably Biology and Microbiology
- Strong operational accuracy and precision