Quality Management Systems Document Specialist 2

Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.

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:

The Document Control Specialist 2 provides support for Humacyte Quality Management Systems specific to the management of regulated documents.  They support Document Control and Administration for the site, including creating, revising, issuing, and controlling cGMP documents and records, and general management of documents processes and systems.  They train staff on Document Control and Administration and oversee document and record retention.  They support internal and external inspections. 

Remote Work Designation: Not Remote

Major Accountabilities:

Under the direction of the Associate Director, Quality Systems, and senior Quality Systems staff:

• Partner in managing quality documentation including, but not limited to the issuance and reconciliation of documents, logbooks and laboratory notebooks.
• Perform general Document Administration for the site, including training staff on associated business and system processes and ability to troubleshoot issues.
• Support the QA Records Room and records retention process, including off-site record storage.
• Support internal and external inspections, participating in inspection readiness activities and document requests in accordance with company policies.
• May own Quality Event records, supports as needed.
• Other duties, as assigned.

Special Competencies:

• Demonstrated background supporting cGMP Quality Management Systems.
• Understanding of Quality Management System strategies and the ability to assist implementation of SOPs, Work Instructions, and related training.
• Excellent problem solving, decision-making ability, and interpersonal skills that enable conflict resolution as related to technical situations.
• Demonstrated ability to work effectively within a team to set goals, develop sound work plans, monitor and communicate progress, and report technical and compliance progress in scientific and industry-standard terms, as required.
• Routinely communicate findings and information to peers and other team members; transparency and knowledge sharing is expected and practiced.
• Familiarity and understanding of cGMP, cGDocP and Data Integrity in regulated pharmaceutical industries.  Understanding of biologics manufacturing operations is preferred.
• Detailed oriented and self-motivated.
• Proficient with Microsoft Office applications.
• Experience with electronic Quality Management Systems a plus.

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:

• High School Diploma or GED, required.  Bachelor’s degree, preferred.
• Minimum 2 years of relevant pharmaceutical, biotechnical, or medical device industry experience (includes Document Administration, Quality Assurance, regulated system administration, training development and delivery)
• Background in one or more specialties in biotechnology: pharmaceutical and/or biological development, biomedical engineering, regenerative medicine, or chemical engineering
• Minimum 2 years of experience in GMP Quality Management Systems
• Strong competency with Excel and Word.
• Experience creating forms and templates, a plus.
• Strong background in both written and oral communication with emphasis on effective technical training
• May be required to work evenings, off-hours, holidays, or extended periods of time.

Perks:

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time and does not accept unsolicited resumes from recruiters.**