Microbiology Lab Analyst

The Microbiology Lab Analyst executes cleaning studies, performs method development, creates test plans, generates reports, and provides data analysis for standard studies within the analytical lab to support critical lab services for external clients.

Responsibilities

• Perform laboratory studies of varying scope and complexity related to cleaning process development. This includes evaluation of residues, screening of cleaning agents, and optimization of critical cleaning variables.
• Perform GMP sample analyis for endotoxin, bioburden and sanitizer efficary testing per USP methods.
• Perform method development and assist in method validation using rinse and swab sampling methodology.
• Generate formalized test plans based on templates and client input to clearly identify the intent and methodology of the studies.
• Analyze experimental data using standardized tools to support conclusions made by the technical resource.
• Review data entry and raw data.
• Generate final reports based on templates to summarize the details and results of the study, including conclusions and recommendations.
• Execute studies with minimal good documentation practice (GDP) and good laboratory practice (GLP) errors.
• Adhere to all laboratory policies and procedures.
  
  
  

Qualifications

• A BS degree in chemistry, biochemistry, or other science related field
• 2 years minimum of microbiology laboratory experience and GxP testing
• Strong verbal and written communication skills, including presentation of data.
• Hands-on analytical laboratory experience.
• The ability to work on multiple projects concurrently.
• The ability to relate with people at all levels within an organization, including diverse cultures
• Awareness of project impact company-wide
• Strong computer knowledge including Microsoft Office products.
• Familiarity with basic statistics and statistical analysis packages.
• A willingness to travel to client sites to perform on-site trainings and qualiifications.
  
  
  

Preferred:

• Knowledge of analytical methods and method validation
• Knowledge of FDA/ICH guidelines
• Knowledge of instrument qualification and operation, especially equipment commonly associated with cleaning studies (ex. TOC, conductivity, pH, UV/Vis)
  
  
  

Pay: $50-60K annually

Are you looking for a meaningful career that makes a difference in the world? Consider joining the Hyde Engineering Consulting team where you will do just that. Hyde E C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers can effectively and safely produce their life-enhancing and often life-saving medicines. To read more about Hyde's culture and benefits, visit our website: www.hyde-ec.com

Hyde Engineering Consulting is an equal opportunity, affirmative action employer.

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