Exela Pharma

Manager, QC Microbiology

Exela Pharma • $75K — $95K *
Lenoir, NC 28645In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Master's or Bachelor's degree in Microbiology or related field.
  • Approximately 5 years of industry experience in Quality Control (QC).
  • Strong leadership skills for managing and developing a team.
  • Proven expertise in cGMP and cGLP regulations.
  • Experience with environmental monitoring and laboratory investigations.

Responsibilities

  • Develop and validate microbiological test methods for pharmaceuticals.
  • Establish and oversee an Environmental Monitoring program per regulatory guidelines.
  • Write and implement Standard Operating Procedures (SOPs) in line with cGMP standards.
  • Conduct internal audits and prepare for external audits by regulatory bodies.
  • Manage the hiring, training, and development of QC microbiology staff.
  • Coordinate and perform disinfectant effectiveness studies and cleaning procedures.
  • Oversee procurement of equipment and resources for the QC microbiology lab.

Benefits

  • Opportunities for ongoing professional development and training.
  • Engagement in cutting-edge projects within pharmaceutical quality control.
  • Supportive work environment focused on employee growth.
  • Potential to directly influence product safety and efficacy in pharmaceuticals.
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 -

About Exela Pharma

Exela Technologies, Inc. is an American business process automation company. It was created with the merger of SourceHOV LCC, Novitex Holdings, Inc. and Quinpario Acquisition Corp. 2. Exela’s software and services include multi-industry department solution suites addressing finance & accounting, human capital management, and legal management, as well as industry-specific solutions for banking, healthcare, insurance, and public sectors. Exela Technology services include workflow automation, digital mail rooms, attended and un-attended cognitive automation, print communications, and payment processing. In 2018 the company declared serving 3,500 customers in more than 50 countries. It has 1,100 onsite client facilities and 150 "delivery centers" in the Americas, Europe and Asian continent. In June 2018, Exela Technologies was listed as a major contender in the Everest Group – "Know your customer-Anti Money Laundering BPO – State of the Market with PEAK Matrix Assessment 2018". In July 2019, Exela Technologies added Martin Akins to their board of directors. In March 2020, Exela completed the divestment of SourceHOV Tax, the company's tax consulting group, for $40 million to private equity firm Gainline Capital Partners. Greenlight Capital is one of the top investors in Exela Technologies. As per the latest financial results published in August 2022, the number of employees stood at approximately 17,500.
Learn more about Exela Pharma
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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