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With moderate supervision, performs routine evaluations of raw materials, finished products, stability and special project test samples as directed by supervisor. Applies sound, scientific principles to solve problems and draw relevant conclusions. With moderate to limited guidance, develops protocols to support the qualification/validation of established procedures or processes.
- Performs routine microbiological analyses and reporting of raw materials, finished products and stability samples.
- Collects and analyzes environmental samples from manufacturing environments and utilities (compressed air, purified water, viable particulates, surface bioburden, etc.)
- Performs basic bioanalytical evaluation of biopharmaceuticals, including but not limited to SDS PAGE, LAL and sub-visible particulatesDevelops basic protocols to support qualification of new materials, products and equipment.
- Reviews/checks data.
Contributes to ensuring lab SOPs/procedures are documented, accurate and up-to-date to industry and customer expectations.
Provides continuous improvement support for established methods and processes through application of sound scientific principles and problem solving
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
Unither is an Equal Opportunity Employer / Affirmative Action Employer Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet
Full the full job description, please click on the link above.
Associates Degree in Life Science Required or Bachelors Degree in Microbiology or Life Science Preferred
One (1) year in an FDA regulated microbiological function preferred
Ability to read, communicate and legibly write in English, analyze and interpret scientific and regulatory documents.
Ability to quickly learn and demonstrate comprehension of cGMP’s and SOP’s.
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.
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