Quality Assurance Associate, GMP
At SAB Biotherapeutics (SAB), we’re using the sophistication of science and genius of nature to change the landscape of human health. Our team of scientists, researchers and professionals has made it their life's work–with technology and tenacity–to pioneer a new powerful platform to make an impact that’s global + personal.
Through advanced genetic engineering and antibody science, we are dedicated to advancing a new class of immunotherapies, leveraging the native human immune response, with first-in-class and best-in-class potential across broad therapeutic categories including autoimmune, inflammation, infectious disease and immune-oncology. SAB-185, is among the elite therapy candidates for COVID-19, advancing with Operation Warp Speed. As true innovation, our novel platform is also being developed in a rapid response capacity for future pandemic response.
The Quality Assurance Associate is an integral part of SAB Biotherapeutics' Quality team contributing to our success by ensuring all documentation, procedures and protocols comply with FDA regulations pertaining to Good Manufacturing Practices (GMP) compliance.
Essential Duties and Responsibilities:
Responsibilities include but are not limited to:
· Manage or participate in internal, external, or regulatory inspections and audits as required.
· Manage the raw material program, which includes, supplier qualification, review and release of raw materials, components, and labels for GMP use.
· Participate in maintaining and monitoring SAB’s quality management system as required to maintain compliance to GMP regulations.
· Review and approve manufacturing production records for compliance to regulations and internal requirements.
· Review and approve test methods, manufacturing/quality control qualification, validations protocols and reports.
· Review executed batch record and testing records for compliance to regulations, internal procedures and protocols.
· Assessment and on-time closure of non-conformance, deviations, and change control requests.
· Perform/review and approve quality investigations or manufacturing deviations, GMP and quality system issues and closure of non-conformances and CAPA activities.
· Review equipment, facility and utility IQ, OQ, PQ documents.
· Assist and/or deliver quality related training to SAB employees pertaining to GMP regulations.
· Support activities as related to qualification/validation of equipment and processes.
· Assist on other projects in the quality department or from other departments as needed. Perform other related duties and assist on other projects in the quality department or other departments as assigned based on company needs.
Supervisory Responsibilities: This position does not supervise employees.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education, Experience and Certifications:
· Bachelor’s degree in a technical field.
· Three years of experience in quality assurance in a pharmaceutical or biotech company required.
· Specific experience working in a FDA-regulated environment.
· Experience reviewing completed manufacturing batch and test records, working knowledge of expectations of qualifying equipment, raw material release.
· Strong knowledge of GMP, SOP’s and quality systems.
Must have strong communication skills. Must be proficient in Microsoft Office software (Word, Excel, PowerPoint and Outlook). Ability to effectively present information in one-on-one, small groups and lab meetings.
Utilizes established mathematical and scientific techniques to compile and analyze data.
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include use of microscopes, close vision, peripheral vision, and the ability to adjust focus.
Normal office environment with some exposure to lab areas. The noise level in the working environment is usually moderate.
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.