Top 2 Natural sciences managers Jobs in Hickory, Nc

Manager, QC Microbiology
Exela Pharma Sciences —Lenoir, NC
- Master's degree
- Bachelor's degree
- Cleaning
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Manager, QC Microbiology

Exela Pharma Sciences -
Lenoir, NC

Quick Apply

Job Details

Qualifications

Workplace health and safety waste management
USP standards
Strategic management
Laboratory safety
GLP
Microbiological culture handling
Master's degree in microbiology
Cleanroom environmental monitoring
Technical documentation
Pharmaceutical regulatory compliance
Corporate training
Hazardous materials handling safety protocols
Industrial ovens
Internal compliance auditing
Microbiological water quality analysis
Cleanroom protocols
Internal investigations
Laboratory test results documentation
Microbiology
Master's degree
Laboratory staff training
Hiring
Schedule management
Laboratory reports
Bachelor's degree
Cleanroom gowning procedures
Scientific protocols
Laboratory standard operating procedures
Compliance documentation
Cleaning

Full Job Description

Position Summary

The QC Microbiology Manager will report directly to quality upper management, (i.e., Director of QC) and will provide both strategic and tactical leadership as part of the QC group. The incumbent will participate in strategic and technical planning for the quality control group, and will be responsible for establishing testing timelines, executing the plan and monitoring the results. The incumbent will be responsible for building, leading and developing a group of quality control microbiologists that support the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration. The individual will be responsible for implementing policies and procedures that improve safety and productivity.

Job Responsibilities

Write and Implement Standard Operating Procedures according to cGMP and cGLP.
Develop and validate new test methods for raw material, in-process, and finished product samples (Sterility, Bioburden and Indicator Organisms, Endotoxin, AET, etc. per USP and FDA guidance)
Establish and implement Environmental Monitoring Program (air, compressed gases, water, surfaces, personnel) per USP, FDA, ISO, and PDA guidelines.
Performance and documentation of laboratory investigations
Develop and perform Disinfectant Effectiveness Studies
Develop and implement cleaning and sterile gowning procedures with the Operations Department
Internal auditing and handling of external audits by customers and FDA during departmental review
Develop and maintain cryo-stored cell line including in house identified isolates
Purchase equipment and materials
Hire and train staff
Assist with autoclave and depyrogentaion oven validations
Manage design and performance of Media Fills with input from Quality Assurance, Validations, and Operations
This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.

Education Requirements

Master’s Degree/Bachelor’s degree in Microbiology or related scientific discipline with approximately 5 years industry in QC -

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Manager, QC Microbiology

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