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:
- 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 and plasma, 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.
Qualifications: 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.