QC Scientist

DESCRIPTION/DUTIES:
The qualified candidate will participate in microbiological method development and method validation in the quality control microbiology laboratory.
Perform all work in compliance with cGMPs, site requirements, USP, FDA and other regulatory body requirements and per standard operating procedures.
Perform traditional microbiology testing (bioburden and LAL) in support of testing, investigations, method development and/or method validation.
Documentation of bioburden and endotoxin (LAL) method validation results on data sheets, in laboratory notebooks, and/or in final reports, as required.
Accountable for the accuracy and validity of testing results.
Review and validate data. Interpret results, perform or review mathematical calculations, and record observations using Laboratory notebooks or other controlled documentation.
Ensure that technical reports, validation reports and other controlled documents are prepared in a timely manner, and review these reports for technical accuracy and compliance.
Oversee maintenance of all related records, and ensure that laboratory work area is maintained in a neat, orderly, and compliant manner.
Suggest continuous improvements to systems, procedures, etc.
Carry out technical and administrative duties as needed.

SKILLS:

QUALIFICATIONS:
Bachelor's Degree in Microbiology, Biology or related scientific discipline.
Minimum of 1 - 2 years of experience in Biopharmaceutical industry, preferably working in a quality control microbiology laboratory.
Familiarity with cGMP would be beneficial.
Working knowledge of traditional microbiological techniques such as spread plating, pour plating, bioburden (membrane filtration) and/or endotoxin (LAL) testing.
Familiarity with documentation and execution of microbiological method validations would be a plus
Proficiency with MS Word and Excel
Understanding of experimental design and scientific methodology in order to plan studies, interpret results, and draw conclusions
Ability to plan and prioritize concurrent assignments/activities
Highly motivated individual who receives minimal supervision on routine assignments
Capability and desire to work as a team member in a fast paced environment.
Good Manufacturing Practices (GMP)