Senior QA Specialist - cGMP Quality Systems Lead

SAB Biotherapeutics, Inc.; Sioux Falls (SD); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

SAB BIO is seeking a Sr. QA Specialist to lead quality system functions in a biotech setting. With 5+ years of QA experience, you will oversee deviations, investigations, change control, CAPA, and documentation to ensure cGMP compliance and product quality.

You will manage batch disposition, material approvals, and internal audits while mentoring junior staff and driving cross-functional improvements. Relocation assistance is available.

Qualifications

• BS/BA in life sciences.
• 5+ years of quality assurance experience in a regulated manufacturing environment (FDA/EMA/MHRA/Health Canada).
• Strong communication skills and ability to present to leadership.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Familiarity with eQMS implementations is highly desirable.

Responsibilities

• Lead QA oversight of manufacturing and QC operations, including batch records review, deviations, investigations, change control, SOPs, and cross-functional liaison.
• Independently lead quality-driven projects and present key quality metrics and validation reviews to leadership.
• Drive ownership of quality systems (change control, CAPA, document management) for process improvement and regulatory alignment.
• Author, review, and approve controlled documents (SOPs, batch records, work instructions).
• Perform batch disposition by reviewing records, testing results, COAs, and quality event closures.
• Inspect and approve raw materials and components against specs and COAs prior to use.
• Provide QA floor support during manufacturing as needed.

Skills

Quality assurance

Communication skills

Project leadership

Data analysis

Education

BS/BA in life sciences

Tools

Microsoft Office

eQMS

Job description

SAB BIO is seeking a Sr. QA Specialist to lead quality system functions in a biotech setting. With 5+ years of QA experience, you will oversee deviations, investigations, change control, CAPA, and documentation to ensure cGMP compliance and product quality.

You will manage batch disposition, material approvals, and internal audits while mentoring junior staff and driving cross-functional improvements. Relocation assistance is available.