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QC Microbiology Associate

Humacyte, Inc. – Research Triangle Park, NC

Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies. We are currently developing multiple vascular tissue engineered therapies and expanding our business model. With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams. We are looking for additional biomedical research and development colleagues to continue to build our expanding team.
Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position reports to Manager, QC Microbiology
  • Perform environmental monitoring sampling (total air particulate, viable surface and air) within classified areas of the facility
  • Participate in the collection of personnel monitoring samples for periodic gowning qualifications
  • Perform Bioburden and Endotoxin testing on in-process and finished product samples
  • Perform media qualification testing on incoming microbiological growth media, sterile rinses and diluents
  • Compile data for quarterly and annual Environmental Monitoring trending reports
  • Participate in nonconformance events and implementation of corrective and preventative actions
  • Assist in authoring and revising standard operating procedures and protocols
  • Assist in managing and purchasing of laboratory consumables
  • Support the Quality Control raw material release program, as required
  • Other duties, as assigned
General Competencies:
  • Possess a positive attitude and optimistic outlook
  • Motivated and organized critical thinker with solid interpersonal and business communication skills
  • Ability to work effectively within a team or individually to set goals, develop sound project plans, monitor progress, and report results scientifically
  • Routinely communicate and present findings and information to other team members; transparency and knowledge sharing is expected and practiced
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Detail-oriented, self-motivated and scientifically driven
  • Strong analytical and problem-solving skills
  • Knowledge of GMP quality systems
  • Ability to work in a cross functional team
Special Competencies:
  • Ability to read and understand compendial guidance documents for microbiological applications, including United States Pharmacopoeia, European Pharmacopoeia, and Japanese Pharmacopoeia
  • Ability to read, understand, and follow all applicable company policies and standard operating procedures
  • Ability to gown for entry into controlled environment manufacturing areas
  • Basic knowledge and understanding of current Good Manufacturing Practices
  • Familiarity with standard laboratory equipment and instruments
  • Effective and timely communication of atypical, aberrant, and out-of-specification test results
  • Ability to recognize and report standard operating procedure deviations
  • Education:
  • Bachelors degree in Microbiology, Biology, Biochemistry or similar field, preferred
  • Experience:
  • 0-3 years of relevant experience and/or training;
  • Or equivalent combination of education and experience
  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 11 Paid Holidays
  • Paid Parental Leave Policies
  • Career Development and Training
**Please note, Humacyte does not provide sponsorship at this time.**

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