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Sr. Document Control Specialist

Regulatory | Research Triangle Park, NC | Full Time

Job Description

About Us:

Humacyte's mission is to become the leading company in novel, off-the-shelf extracellular matrix tissue products, and especially those that could provide lifesaving improvements in treatments for vascular conditions.

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.

Responsibilities:

  • Participate and support with Manufacturing and Laboratory investigations and deviations ensuring the development of Corrective Actions and Preventative Actions as necessary.

  • Maintains facility certifications and regulatory licenses. Provides documentation to auditors, applies for renewals, and participates in certification audits.

  • Assists in efforts to educate and train personnel as it relates to the QT9 QMS system. Conducts training specifically for bioprocessing operators and regularly follows up with employees to ensure that they understand the requirements of their jobs.

  • Facilitates documentation activities to meet quality/manufacturing specifications and regulatory standards by providing training, auditing, troubleshooting and incident management.

  • Develops, implements, and delivers training on QA procedures and GMPs.

  • Supports the QA process and workflow functions to achieve department goals.

  •  Manage batch related documentation including but not limited to issuance and management of batch records, logbooks and laboratory notebooks.

  • Assist in implementing and maintaining the quality systems programs for the Humacyte facility.

  • Independently create, review, and revise standard operating procedures

  • Manage Document Control Room and off-site record retention process.

Requirements:

  • Bachelor's Degree

  • Minimum 8 years of relevant pharmaceutical industry experience

  • Five to eight years of experience in a GMP document control environment

  • Proficient in MS Word, Excel, Outlook, Quality Management Systems and familiar with MRP/ERP systems

  • Strong organization skills
  • Ability to communicate with regulatory agencies, when applicable

Bonus Points:

  • Manage and track Deviations, Investigations, and Product Complaints and works with other departments to resolve in a timely manner.

  • Review all Policies, SOPs, Work Instructions, Forms, and Templates and manages QA-related document control.

  •  Implement continuous improvement through utilization of Quality Management System (QT9), Standard Operating Procedures (SOP) and other information systems as needed.

  •  Review documentation for accuracy and conformance to established guidelines, polices, and practices.

  • Conduct and support internal audits in accordance with company policies.  

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 3 Weeks’ Vacation
  • 5 Personal Floating Days
  • 8 Sick Days
  • 6 Company Holidays
  • Career Development and Training