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Quality Specialist III

3 months ago

Durham, United States HUMACYTE GLOBAL INC Full time
Job DescriptionJob Description

Quality Specialist III


JOB SUMMARY:

The Quality Specialist 3 provides support to the overall Quality Assurance program at the site. Ensures manufacturing operations are within cGMP and GTP regulations and local procedures.

ESSENTIAL FUNCTIONS:

  • Lead and provide oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise
  • Review and approve production batch records to ensure adherence to Humacyte policies, SOPs, and cGMP requirements
  • Conduct QA Batch Release on clinical and commercial batches per company disposition procedures
  • Initiate and own quality records (Change control, CAPA, deviation)
  • Collaborate cross-functionally to resolve outstanding issues ranging from simple to diverse complexity and scope from the manufacturer or testing of the batch (e.g., batch record review, investigations, testing, change controls, etc.) to ensure the timely submission/release of the material
  • Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Humacyte quality practices and make informed recommendations for resolution
  • Create, write, review and approve QA dept Standard Operating Procedures (SOPs), as needed.
  • Represent Humacyte Quality by interacting with FDA, partner and supplier auditors/inspectors as needed
  • Represent Quality Assurance on project teams and in meetings
  • Assists Mentor and trains team


EXPERIENCE & QUALIFICATIONS:

  • Bachelor’s degree, required. Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Biology or Chemistry, preferred
  • Minimum 5 years of pharmaceutical work experience, preferably in Biologics manufacturing
  • Demonstrated background in support of cGMP Quality management systems
  • Experience in evaluating technical quality problems and providing recommendations for corrective actions
  • Firm understanding of Quality Management Systems processes and the ability to lead investigations
  • ASQ certification a plus
  • Understanding of cGMP, ISO and ICH guidance’s in the biotech manufacturing environment
  • Process Excellence training, strongly preferred
  • Strong familiarity with inspection methods and techniques, preferred
  • Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment, preferred
  • Experience with product release
  • Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
  • May be required to work evenings, off-hours, holidays or extended periods of time
  • Strong understanding of cGMP, ISO and ICH guidance’s in the biotech manufacturing environment


COMPENSATION & BENEFITS HIGHLIGHTS:

  • 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 U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.