Microbiology Scientist I

Unifin SAS • Rochester, NY

8d

About The Position

Reporting to the Microbiology Supervisor,
JOB SUMMARY:
Perform routine evaluations of raw materials, finished products, components, stability, and special project test samples as directed by supervisor. Perform development evaluation of new raw materials and finished products as directed and document results in scientific reports. Supports laboratory to ensure laboratory procedures, equipment, supplies, and inventory are available for routine testing, monitoring, and for qualification and implementation of new tests and equipment. Support the qualification/validation of equipment and new processes.

Requirements

• Associate’s Degree in Life Sciences (Bachelor’s Degree in Microbiology or Life Sciences preferred).
• Minimum of three (3) years in an FDA regulated, directly relevant microbiological function preferred.
• Ability to read, communicate, and legibly write in English, analyze and interpret scientific and regulatory documents.
• Ability to apply and understand general mathematical concepts such as exponents, averages, and logarithms.
• Ability to apply principles of logical and scientific thinking to a wide range of practical and applied problems.
• Ability to work independently and in a team environment and take the initiative to learn new techniques.
• Effective planning, organization, and prioritizing of multiple work assignments and/or projects.
• Ability to quickly learn and demonstrate comprehension of cGMP’s and SOP’s.
• Must have excellent attention to detail and the ability to follow procedures and perform tasks with a high degree of accuracy and quality.
• Ability to identify potential issues before they impact manufacturing and packaging operations.
• Ability to analyze problems via the scientific method and draw data supported conclusions.
• Demonstrable applied microbiological skills.
• Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating and using personal folders, scheduling appointments, working with meeting requests and managing tasks.
• Intermediate Microsoft Word skills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files; create moderately complex documents containing tables and graphs, and ability to mail merge documents, apply page setup functions (margins, page numbers, footers, headers), create an index and/or table of contents, use search & replace, print labels and envelopes; as well as create and protect forms, use graphics, outline and organize long documents, create cross references, captions and bookmarks; use master documents to manage long documents, and create and use document templates.
• Intermediate Excel skills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data, link data, create and edit charts, change page orientation, add headers and footers, filter and sort lists, format data, insert rows, enter and sort data and produce graphs and charts; as well as the ability to enter and edit complex formulas, filter lists, sort ranges, create and run macros, and use data analysis tools (pivot tables, scenarios, etc.)
• Basic PowerPoint skills as evidenced by the ability to create and save a presentation, add titles, edit and delete slides, reordering slides, applying slide masters, checking spelling, and adding clip art; as well as use and print notes, changing color schemes, changing fonts, bullets, slide backgrounds; adding a table, changing a slide layout, adding a chart, creating organizational charts, and search & replace.

Nice To Haves

• Bachelor’s Degree in Microbiology or Life Sciences preferred.
• Minimum of three (3) years in an FDA regulated, directly relevant microbiological function preferred.

Responsibilities

• Sample Testing and Environmental Monitoring
• Perform routine microbiological analyses and reporting of raw materials, components, finished products, stability samples, and sample requests.
• Perform environmental monitoring of purified water, water for injection, pure steam, compressed air, and non-sterile manufacturing operations.
• Handle and reconcile controlled substances.
• Participate in investigations.
• Perform Visual Inspection Testing.
• Perform Particulate Matter Testing.
• Handle Biological Indicators.
• Maintain Stock Cultures.
• Perform Microbial Identifications and apply further microbial assessment as needed.
• Perform sterility testing of sterile finished products.
• Perform bacterial endotoxin testing of raw materials and finished products.
• Support qualifications of new materials, products, and equipment. Document results in reports.
• Review/check data.
• Laboratory Environment Maintained to GMP Standards
• Contribute to ensuring laboratory Standard Operating Procedures (SOPs) are documented, accurate, and up-to-date to industry and customer expectations.
• Provide continuous improvement support for established methods and processes.
• Safe, Compliant, Efficient Labs
• Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, CDC/NIH and OSHA regulations.
• Maintains accurate and orderly records

Benefits

• 100% employer-paid medical premiums (a $2,000–$6,000+ annual value)
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 1,001-5,000 employees