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Document Specialist II

All Openings | Research Triangle Park, NC | Full Time

Job Description

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 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 Background:

This position reports to Director, Bioprocessing

Major Accountabilities:

  • Responsible for creation, modification, and maintenance of SOPs.  Specifically, for implementation of the QT9 Quality document system  
  • Responsible for creation, modification, and maintenance of Training Qualification Records (TQRs) used to train personnel on processes
  • Responsible for creation, modification, and maintenance of Bill of Materials (BOMs) for production use and coordination with the inventory management team, as needed
  • Batch record review for Operations and able to get corrections completed in a timely manner to meet lot release on time (LROT)
  • Maintain the integrity of the document system
  • Document activities in accordance with cGMPs
  • Support Qualification and Validation activities
  • Support of Inoculation day activities for bioprocessing
  • Responsible for creation, modification, and maintenance of batch records
  • Subject Matter Expert in Quality Management System (QMS) associated with documentation
  • Trained on basic processes and document systems
  • Other duties, as assigned

Special Competencies:

  • Works within clearly defined standard operating procedures (SOPs) and/or scientific methods
  • Applies analytical skills or scientific methods or operational process to perform routine activities
  • Able 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

General Competencies:

  • Able to communicate effectively in English, both verbally and in writing

  • Possess a positive roll-up-the-sleeves attitude and optimistic outlook

  • Represents the organization in a positive and professional manner

  • 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

  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook

  • Must be able to work as needed to meet tight deadlines and at peak periods

  • Self-motivated and organized critical thinker with solid interpersonal and business communication skills

  • Demonstrated ability to work in a cross functional team

  • Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements

  • Always observe safety precautions and regulations in all areas where duties are performed

  • Responsible for reporting all safety hazards and potential unsafe working conditions

  • Reports to work on time and as scheduled

QUALIFICATIONS:

  • Bachelor’s degree in science, preferred
  • 3+ years of experience in pharmaceutical, biotechnology, and/or sterile production environments, preferred
  • Basic knowledge of cGMP requirements
  • 3+ years of experience writing and modifying SOPs, batch records, and TQRs preferred
  • History of technical writing abilities
  • Experience performing batch record review, required
  • Experience with aseptic technique

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 12 Paid Holidays
  • Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time.**