QA Associate, Animal - Compliance & Audits

SAb Biotherapeutics, Inc.; South Dakota; On-site; USD 65,000 - 90,000; Full time

Job summary

SAB BIO is seeking a Quality Assurance Associate, Animal to join our QA team in the United States. You will help ensure that all documentation, procedures and protocols in our animal production and drug manufacturing operations meet GACUP, GVCP, GLP and cGMP requirements.

Your duties include performing audits, reviewing records, supporting AAALAC accreditation activities, approving controlled documents, reviewing data for regulatory compliance, and aiding with qualification/validation efforts.

Qualifications

• QA experience in a regulated environment
• Strong verbal and written communication skills
• Proficiency in MS Office applications (Word, Excel, PowerPoint, Outlook)
• Familiar with eQMS functionality
• Ability to compile and analyze data

Responsibilities

• Perform audits and review records to support regulatory compliance.
• Support QA audits and inspections to ensure regulatory compliance.
• Collaborate with other departments on deviations and CAPA activities.
• Review and approve controlled documents for regulatory compliance.
• Review protocols, reports, data for compliance with regulations and good documentation practices.
• Assist with qualification/validation activities.
• Support other QA or internal projects as needed.

Skills

Quality Assurance

Verbal & written communication

Data analysis

Microsoft Office

Education

BS in biological sciences

Tools

eQMS

Job description

SAB BIO is seeking a Quality Assurance Associate, Animal to join our QA team in the United States. You will help ensure that all documentation, procedures and protocols in our animal production and drug manufacturing operations meet GACUP, GVCP, GLP and cGMP requirements.

Your duties include performing audits, reviewing records, supporting AAALAC accreditation activities, approving controlled documents, reviewing data for regulatory compliance, and aiding with qualification/validation efforts.