HUMACYTE Bioprocessing Deviation Writer Salary in the United States

 Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies.  Humacyte has a rich history of scientific research and discovery.   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 to continue building 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 demonstrate the ability to work in a team environment, and lead other professionals and peers.

Position Background:

The Deviation Writer will use the knowledge of the Human Acellular Vessel (HAV) process to write technical documents. This position reports to Associate Director, Bioprocessing

Primary Responsibilities: 

• Creation of Nonconformance Events (NCEs) in a timely manner to support batch release
• Conduct investigations with associates involved in NCEs or deviations
• Work closely with Bioprocessing and Quality personnel to write and submit NCEs
• Under the guidance of the Associate Director, develop and sustain deviation metrics and maintain the general health of the deviation system  
• Coordinate Bioprocessing departmental NCE program to track status and ownership
• Document activities in accordance with cGMPs
• Support the Change Control and CAPA programs
• Conducts all assigned activities in a safe and GMP manner
• Trained on basic processes and document systems
• Discuss NCEs with regulatory agencies, as applicable and needed
• Other duties, as assigned

Key Competencies: 

General

• Possess a positive attitude and optimistic outlook
• High attention to detail and ability to drive results
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Strong communication (verbal and written) and organizational skills
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Motivated and organized critical thinker with the ability to effectively communicate to supervisor and peers
• Routinely communicate findings and information to peers and other team members; transparency and knowledge sharing is expected and practiced

Specific 

• Works within clearly defined standard operating procedures (SOPs) and/or scientific methods.
• Applies basic analytical skills or scientific methods or operational process to perform routine activities.
• Ability to troubleshoot
• Understands how the assigned duties relate to others in the team and has a basic understanding of how the team integrates with others
• Works as a team player, participating in activities that involve cooperating with others
• Strong technical writing ability  

Qualifications:

 Education:

• Bachelor’s degree in science, preferred

 Experience:

• Experience writing and modifying deviations, CAPAs, and change controls
• Demonstrated technical writing ability
• Basic knowledge of cGMP requirements preferred
• Experience in pharmaceutical, biotechnology, and/or sterile production environments, preferred