Nitto Avecia Pharma Services in Irvine, CA is looking for a Microbiologist I to support the daily operations of the Microbiology Department. If you have experience in performing microbiological testing of raw materials, intermediates, API, drug product release and stability samples, as well as collection and testing of environmental monitoring samples, in accordance with cGMP requirements in a CMO or CRO organization and are ready to make a move to a highly respected company in the pharmaceutical industry, this is the opportunity for you.
The Microbiologist I position offers a competitive salary with excellent benefits, including medical, dental, and vision that are available on the first of the month following the first day of employment.What you will be doing
As a Microbiologist I, you will perform routine microbiological laboratory analysis, such as Environmental Monitoring, Bioburden, Microbial Limits (preparatory & screening), Sterility, Endotoxin (Gel-Clot & Kinetic methods), operate autoclave, and prepare media in accordance with Customer, schedule and cGMP requirements.
Read and understand test methodologies, study protocols, and Standard Operating Procedures in order to review or execute testing in compliance with necessary policies and procedures. Record/review data in controlled notebooks, data sheets, and electronic systems (i.e. LIMS, etc.) in accordance with cGMP requirements.
Work on routine tasks where analysis of situations or data requires review and evaluation of limited factors, limited judgment is required in resolving problems and making routine recommendations. Exercise judgment within defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
Assume ownership of assigned quality documentation, such as exceptions, change controls, and CAPAs, ensuring that documentation is initiated and closed on time, required actions are thorough and meet procedural requirements as well as customer needs.
Abide by safe work practices and adhere to general safety rules, performing all duties in a safe manner and never placing yourself or those around you in an unsafe condition. Report all unsafe conditions to your supervisor.Qualifications - Experience and Education:
Knowledge, Skills, and Abilities:
- A minimum of 1 years, 2+ years preferred, industry related work experience
- Bachelor's degree or equivalent in scientific discipline required.
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- Knowledge of cGMP regulations, and FDA and ICH guidelines as they pertain to aseptic manufacturing operations.
- Knowledge of USP, Pharm. Eur. and other compendial methods and procedures.
- Knowledge of microbiological practices, procedures, and common analyses, such as Bioburden, Microbial Limits (preparatory & screening), Sterility, Endotoxin (Gel-Clot & Kinetic Chromogenic methods), validation - Inhibition/Enhancement Sterility Test Method Validation (Bacteriostasis/Fungistasis), and Preservative Efficacy Testing.
- Knowledge in the use of LIMS and electronic documentation systems (i.e. SmartSolve).
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, etc.).
- Strong interpersonal skills. Must be able to express oral and written communication in a clear and concise manner and effectively present information and respond to questions from managers, customers and employees.
- Effective organizational and time management skills with the ability to multi-task and prioritize assignments as needed.
- Ability to work effectively under pressure in a rapidly changing environment.
- Ability to work well independently and effectively with a wide variety of colleagues both inter- and intra- departmentally.
- Ability to understand and apply technical concepts to laboratory operations developing solutions to problems that require ingenuity, creativity, and innovation.
- Ability to seek critical information from key resources to assist in problem solving.