Quality Control Analyst (Day Shift-Microbiology)

Location
Libertyville, IL, US
Posted
Oct 28, 2020
Ref
5719
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The QC Analyst provides Environmental Monitoring (EM) and Microbiological expertise at the Novartis Gene Therapies GMP Manufacturing facility in Libertyville IL. Responsibilities include, but are not limited to environmental monitoring, routine testing, method qualification/validations, excursion notifications, and trend reports and other associated activities. A potential candidate will possess an understanding of Environmental Monitoring and Microbiological techniques. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations. The QC Analyst may also support the Manager for activities related to training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. The QC Analyst should be able to work effectively within the group, within Quality, and across site.

Responsibilities
  • Perform environmental monitoring for HVAC (viable air, viable surface, total particulates), purified water (conductivity, TOC, bioburden) and compressed gases (hydrocarbon, dew point and bioburden) systems. Serve as subject matter expert in this area.
  • Review and trend EM data and publish quarterly and annual trend reports.
  • Conduct thorough investigations to determine root cause of environmental excursions and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
  • Establish and maintain library of environmental isolates.
  • Perform microbiological testing such as bioburden, endotoxin, growth promotion, viability and gram staining, etc.
  • Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
  • Perform other established analytical methods such as BCA, SDS-PAGE, TOC, conductivity, and pH testing to support QC operations.
  • Participate in assay troubleshooting, qualification and validation.
  • Manage the use and maintenance of scientific equipment and instrumentation, computer systems;
  • Write and revise documents such as SOPs and technical reports.

Qualifications
  • Minimum B.A. or B.S. in microbiology or related scientific field
  • Minimum of 2 years of environmental monitoring and microbiology experience in a GMP laboratory.
  • Excellent oral and written communication skills with strong technical writing experience required.

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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