Metrology Compliance Specialist

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 Metrology Compliance Specialist supports the Metrology Services Department as a part of a rapidly expanding GMP Manufacturing Operation. The Specialist will need to produce high-quality documentation by reviewing of the departments calibration and Maintenance records for accuracy and compliance with the appropriate procedure. The candidate will ensure that department compliance measures are maintained, all documentation meets regulatory requirements, and is completed according the determined target timelines. The Specialist will be responsible for the completion of Metrology Services Change Controls, CAPAs, Deviations, Risk Assessments, SOPs, and other quality documentation. Understand GxPs, nonconformities, Good Documentation Practices, calibration, equipment maintenance, etc. Ensure that SOP, procedures, specifications and calibration and Maintenance dates are current and appropriately captured. Identification of quality issues and ability to take quick corrective action. Assists in the corrective and preventive action process. Verify reverse traceability and to conduct risk assessments when reference standards are found out of tolerance. Communicate information to all relevant departments, outside vendors or contractor.

Additional duties include the writing, review, approval, and maintenance of GMP and non-GMP documentation including Standard Operating Procedures (SOPs), Non-Conformance reports, and calibration records

This position reports to the Director, Site Engineering

Remote Work Designation: Partially Remote

Major Accountabilities:

• Partner with Quality, Engineering and Operations groups to always ensure strict compliance with CMMS cGMP/GLP guidelines
• Measure and assist with reporting of KPI metrics daily/weekly by improving processes, helping interpret facts and data, and by making sound recommendations based on quantitative and qualitative date
• Measure and publish facility’s PI metrics to the management team; interpret data, troubleshoot processes and make recommendations based on findings
• Coordinates outside calibration activities with vendors.
• CAPA System: Utilize this Quality system to evaluate identifiable factors to solve problems diverse in scope and implement continuous improvement corrective and preventive actions for system level improvements.
• Change Control System: Identify and initiate changes through collaborative efforts with Quality Assurance and applicable departments in response to deviations, CAPA’s and departmental continuous improvement projects.
• Utilizes multifunctional teams to implement process and continuous improvements within Quality Systems (Deviation, CAPA, CC, SOPs, Risk Analysis, Root Cause Analysis, etc.)
• Support Facility Maintenance, and Metrology in the development and revision of Standard Operating Procedures (SOPs), completion of periodic reviews, and other quality documentation.
• Assist in generation of departmental quality metrics and track the status of active records.
• Other duties, as assigned

Special Competencies:

• Basic understanding and application of instrument, equipment, calibration, and maintenance of various parameters in manufacturing, utilities, and laboratory environments within a cGMP Biotechnology / Pharmaceutical manufacturing environment.
• Understanding of Traceability, Substitution of Standards, and Test Accuracy and Uncertainty Ratios.
• Able to make independent decisions within defined scope of work, seeks clarification and directions when needed. Must be self-driven and demonstrate ability to work with little direction
• Proven knowledge of a Computerized Maintenance Management System (CMMS)
• Strong organizational and planning skills required
• Excellent interpersonal effectiveness and communication skills (written and oral) are required to interface across management levels and departments
• Works as a team player, and serves as a model by 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:

• Associates Degree in Engineering, Life Sciences or other related technical field, required or equivalent military training. Bachelor’s degree, preferred
• 3+ year Data management and documentation, CMMS experience, required
• 5 years of Quality System/Pharmaceutical experience, preferred
• Will be required to regularly to sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
• Position may require working some over-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.**