QC Microbiologist

Job SummarySupports laboratory instrument qualification and microbiological method validation activities in the Quality Control Laboratory. Develops and implements microbiological methods including environmental monitoring, USP Purified Water Testing and WIFI Water testing. Responsible for all microbiological aspects of the site.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
- Develops and writes microbiological methods and assures microbiological validation protocols meet requirements for regulated and non-regulated products. The test methods included in scope include Bioburden, Yeast & Mold, Sterility, Endotoxin (LAL), nuclease and protease.
- Executes method validation protocols, and summarizes execution of method validation activities in a written report. Creates and writes laboratory methods for use in routine laboratory testing.
- Develop and implement an Environmental Monitoring program for the site.
- Complete the PM for Water System Monitoring and review results for trends and recommend actions where appropriate.
- Assure laboratory personnel are properly trained for microbiological activities where appropriate.
- Understands governing principles for microbiological methods, USP , USP , USP , ICH QB4, annex 4AR1, 4BR1, 4CR1, ISO 17025. USP Purified Water and USP WIFI Water systems.
- Assist with selection and purchase of laboratory instruments for the QC laboratory.
- Writes and/or executes laboratory microbiological instrument qualifications, IQ, OQ and PQ when required.
- Prepare and implements SOPs, methods, protocols and other laboratory documentation as necessary and appropriate.
- Complete microbiological work in an appropriate and timely manner to meet the needs of the protocols, customers, and company requirements.
- Work together with Operations, QA/QC, Validations, Product Design & Engineering and other relevant departments to develop microbiological strategies for new or existing products.
- Guide and direct the policy and procedures for environmental monitoring program for classified clean room areas.
- Supports or leads any necessary investigations or training in the area of microbiology.
- Proactively maintain current industry and regulatory knowledge for microbiological method validation, GMP principles and compendia methods.
- Performs other duties as assigned.
QUALIFICATIONS (Education/Training, Experience and Certifications)
- Bachelor's degree in Microbiology, Biology or Science related field
- 5 years of applicable experience in microbiological testing, environmental monitoring, or related experience.
- Experience in Purified and/or WIFI Water System monitoring and testing preferred.
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
- Familiarity with MS Office (Word, Excel, Access)
- Strong interpersonal and organizational skills
- Ability to work in a team environment
- Ability to analyze, investigate and propose approaches to technical and regulatory issues
- Ability to design, execute and analyze microbiological validation studies
- Ability to manage multiple concurrent tasks/studies
- Ability to identify, analyze and resolve problems that may be complex in nature
- Strong attention to detail
- Strong communication skills
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
Typically works in a lab environment with adequate lighting and ventilation and a normal range of temperature and noise level. At times, may be exposed to a variety of different chemicals including flammables, corrosives, oxidizers and others.
Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
A frequent volume of work and deadlines impose strain on routine basis.
Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.
DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Avantor is proud to be an equal opportunity employer.
EEO Statement
We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at TalentManagement@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
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