The 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 Remote

Major Accountabilities:

• Assist in implementing and maintaining the quality systems programs including but not limited to:

o deviation management

o change control

o corrective and preventative action

o 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 assigned

Special 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 guidelines

General 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