Microbiologist I
2 months ago
Under limited supervision and guidance of the Microbiology management team, the Microbiologist responsible for: testing of finished products, bulks, and raw materials using various microbial analysis. Read, calculated, and recorded analysis data to produce a report. Responsible for PET, Method suitability, Growth Promotion, water testing and Environmental testing.
Primary Duties and Responsibilities:
- Performs routine microbiological testing of products, raw materials, components, and controlled environments according to site Standard Operating Procedures and compendial methods.
- Bioburden Testing by rapid and pour plate method.
- Bringing samples, sorting, logging into books and get ready for testing.
- Aseptically Testing FG, Bulks and RM.
- Environmental testing (Production rooms, Manufacturing areas and warehouse with sampling booth).
- Total Heterotrophic Plate count of potable and process water.
- Preparation, sterilization, incubation, and growth promotion of culture media.
- Preparation and inventory of cultures for routine use.
- Identification of microbial organisms.
- Documents routine procedures following laboratory and company guidelines.
- Data entry using Good Documentation Practices.
- Assists in non-conformance investigations including deviations, and OOT/OOS related to product results.
- PET and Method Suitability for all OTC finished products.
- Cleaning of Incubators and Refrigerators.
- Calibration of Lab equipment's.
- Review books, binding new books, and organizing the lab documents.
- Perform other tasks as assigned by the Manager.
Working Relationships/Key stakeholders:
Solid and Cooperative working relationships with planning, production, purchasing, accounting, warehousing, and human resources departments.
Qualifications & Competencies:
- Bachelor’s degree in scientific discipline required. Four - Five years’ experience in the GMP industry environment preferably a Microbiology or Environmental laboratory.
- Ability to meet attendance standards, required to work a minimum 40-hr week.
- Must be detail-oriented, precise, and consistent in laboratory data entries and stability sample information in the stability database.
- Must be flexible to adapt to changes in assignment and be ready to accept any work assigned by laboratory management.
- Strong skills with Microsoft Office applications (Excel, Office, PowerPoint, Outlook, etc.)
- Extensive knowledge of cGMP & GLP.
- Knowledge and understanding of domestic & international regulations (FDA, TGA and ICH), guidelines and practices for cosmetics and OTC products.
- Computer proficiency in MS word, excel, outlook, ability to use enterprise software, preferably LIMS or related systems.
- Is open-minded, self-confident, self-motivated, and cooperative.
- Must be detail oriented, ability to work as a team with strong interpersonal, organizational, and communication skills.
- Is enthusiastic about problem solving and motivational toward the team.
Our Principles serve as the working principles that every Shiseido employee must follow. These eight working principles – known as “TRUST 8” – are based on the idea that mutual trust is the key to succeeding in Our Mission.
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THINK BIG – Adapt a big-picture perspective. Deliver new values through creativity.
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TAKE RISKS – Embrace risk. Practice “Trial & Error & Trial”.
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HANDS ON – Consider front-line realities when making decisions. Take the lead from end-to-end.
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COLLABORATE – Break free from the silo mentality. Leverage the diverse capabilities of colleagues.
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BE OPEN – Be transparent. Create an environment that encourages everyone to speak up – even if it is bad news.
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ACT WITH INTEGRITY – Be sincere and humble at all times.
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BE ACCOUNTABLE – Commit to the goal. Take accountability for the execution.
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APPLAUD SUCCESS – Create a culture that celebrates success.