Advanced Recruiting Partners

The Quality Specialist II provides support to the overall Quality Assurance program at the site.. Conduct batch record review for clinical and commercial product manufactured for Humacyte. General understanding of cGMP, ISO and ICH guidance’s in the biotech manufacturing environment. Demonstrated background in support of GMP Quality management systems,. Background in one or more specialties of biotechnology: bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, cell biology, chemical engineering, and/or biochemical engineering

quality specialist ii

Position Background:The Quality Specialist II provides support to the overall Quality Assurance program at the site. Ensures manufacturing operations are within cGMP and GTP regulations and company procedures.Remote Work Designation: Not RemoteMajor Accountabilities:• Assist in implementing and maintaining the quality systems programs including but not limited to:o deviation managemento change controlo corrective and preventative actiono material controls/material management• Conduct batch record review for clinical and commercial product manufactured for Humacyte• Maintain approved labeling materials and process/distribute per company procedures• Under limited direction and supervision, create, review, and revise standard operating procedures• Support and contribute to quality improvement initiatives• Participate in team meetings and make recommendations related to changes in processes, process improvements and provide suggestions as needed• Assist in the internal audits as required• Other duties, as assignedSpecial Competencies:• Demonstrate strong critical thinking skills with the ability to motivate others• Ability to work effectively within a team to set goals, resolve compliance issues 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• Contributes to the development, implementation and execution of quality systems programs, as required• General understanding of cGMP, ISO and ICH guidance’s in the biotech manufacturing environment• General understanding of biologics manufacturing operations,• Demonstrated background in support of GMP Quality management systems,• Experience in evaluating technical quality problems and providing recommendations for corrective actions• Detailed oriented, self-motivated and scientifically driven• Ability to assist in resolving processing challenges within manufacturing• Excellent problem solving, decision-making ability, and interpersonal skills that enables conflict resolution as related to technical situations• Firm understanding of Quality Management Systems processes and the ability to lead investigations• 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 guidelinesGeneral Competencies:• Able to communicate effectively in English, both verbally and in writing• Excellent communication and interpersonal skills• Possess a positive roll-up-the-sleeves attitude and optimistic outlook.• 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.• Ensures Humacyte or other required trainings/certifications are up to date.• Represents the organization in a positive and professional manner.• Reports to work on time and as scheduled.Qualifications:• Bachelor’s degree, required• Minimum 2-4 years of relevant pharmaceutical, biotechnology or medical device industry experience• Background in one or more specialties of biotechnology: bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, cell biology, chemical engineering, and/or biochemical engineering• Experience executing validations plans and reviewing validation protocols, reports and technical documents.• Process Excellence training, preferred• ASQ certification, preferred• 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• May be required to work evenings, off-hours, holidays or extended periods of time• 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#IND

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