QC Supervisor, Microbiology

Exela Pharma Sciences•Lenoir, NC

About The Position

The Supervisor, Microbiology will report the Director, Microbiology. The incumbent will be responsible for establishing testing timelines, executing the plan, and monitoring the results.

Requirements

Minimum of five years of experience in a QC Microbiology Laboratory.
Must demonstrate proficiency in microbiology laboratory techniques such as water analysis by membrane filtration, endotoxin analysis, sterility analysis, and identification.
Previous supervisor experience or demonstrated skills to lead/mentor a group cohesively and effectively.
Bachelor’s degree in Microbiology or related scientific discipline.

Responsibilities

Assist with writing and implementing SOP’s, work instructions and protocols according to cGMP and cGLP.
Performance and documentation of laboratory investigations.
Perform internal auditing and assistance in handling of external audits by customers and FDA during departmental review.
Develop and maintain cryo-stored cell line including in house identified isolates
Submit purchase orders for equipment and materials.
Interview potential candidates and onboard new employees.
Assist with autoclave and depyrogentaion oven validations.
Generate staff shift and schedules aligned with required QC and manufacturing support functions.
Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
Maintain the safety and orderliness of the lab; apply knowledge of cGMPs and GLPs daily.
Perform training on laboratory methods and instrumentation.
Complete Resource Conservation and Recovery Act training within 6 months of hire and annually thereafter.
Perform other duties as assigned.