Charles River Laboratories

Investigations & Continuous Improvement Coordinator

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Job Description

We are seeking an Investigations & Continuous Improvement Coordinator for our Microbial Solutions site located in Charleston, SC.

Technical SME in the manufacture and testing of Microbial Solutions’ product lines, including both LAL& Celsis rapid microbiology.  Responsible for designing and executing test batches / testing methods to support manufacturing and continuous improvement initiatives.

The following are the job responsibilities related to the Investigations & Continuous Improvement Coordinator:

•    Designs pilot scale batch manufacturing & testing to support root cause investigation, CAPA & continuous improvement initiatives.
•    Oversees the manufacture and testing performed by technicians
•    Responsible for managing documentation of associated activities
•    Prepare reports summarizing work performed, evaluating results, and providing conclusions.
•    Oversee new product transfer from R&D team to Manufacturing, including:
•    Pilot batch manufacturing
•    Stability / equivalency studies
•    Development of in-process & QC test methods and specifications
•    PPQ batch production
•    Change control documentation
•    Perform laboratory activities necessary to isolate, frow and maintain bacterial cultures
•    Perform microbiological, endotoxin, and ATP analysis utilizing varying instrument platforms
•    Responsible for proficiency in all departmental SOPs.
•    Responsible for documentation as required by FDA, company policy, and cGMP.
•    Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews
•    Perform other related duties as assigned.

Job Qualifications
The following are the minimum qualifications related to the Investigations & Continuous Improvement Coordinator:

•    Education:  Bachelor’s degree in Microbiology, Master’s preferred.
•    Experience:  5+ years related experience in a laboratory or aseptic or sterile production / fill operations.
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Certification/Licensure:  none

Job Summary

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Charleston, SC Location
Full Time Job Type
Charles River Laboratories

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