Senior Quality Assurance Specialist

SAB BIO; Sioux Falls (SD); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

SAB BIO is seeking a Senior Quality Assurance Specialist to lead key quality system functions and ensure cGMP compliance in a biotech setting. With 4+ years of experience, you will manage investigations, CAPA, change control, and mentor junior QA staff.

The role supports regulatory inspections, cross-functional collaboration, and continuous improvement, with relocation assistance available for onsite work in Sioux Falls.

Qualifications

• BS/BA in life sciences.
• 5+ years of quality assurance experience in a regulated manufacturing environment; pharma or related industry preferred.
• Strong communication skills and proficiency in Microsoft Office.
• Ability to effectively present information in one-on-one, small groups, and company meetings.
• Proficiency in applying mathematical and scientific techniques to compile and analyze data.
• Familiarity with eQMS functionality; experience implementing an eQMS is highly desirable.

Responsibilities

• Lead QA oversight of manufacturing and QC, including batch review, deviation investigations, and cross-functional liaison to ensure compliance with cGMP and internal quality standards.
• Independently lead quality-driven projects and present key quality metrics, training initiatives, and validation documentation reviews to leadership and cross-functional teams.
• Drive ownership of quality systems, including change control, CAPA, and document management, with accountability for process improvement and regulatory alignment.
• Other duties/responsibilities as assigned.

Skills

Quality assurance

Communication

Data analysis

Presentation skills

Continuous improvement

Education

BS/BA in life sciences

Tools

MS Office

eQMS

Job description

The Senior Quality Assurance Specialist leads key quality system functions to ensure compliance with cGMP and regulatory standards in a biotech environment. With over four years of experience, this role manages complex investigations, oversees change control and CAPA processes, supports regulatory inspections, and mentors junior QA staff. The specialist drives continuous improvement and cross‑functional collaboration to uphold product quality and operational excellence.

Some relocation assistance is available for this onsite role.

Duties and Responsibilities

• Lead and execute quality oversight of manufacturing and QC operations, including batch record review, deviation investigations, and cross‑functional liaison to ensure compliance with cGMP and internal quality standards.
• Independently lead quality‑driven projects and present key quality metrics, training initiatives, and validation documentation reviews to leadership and cross‑functional teams.
• Drive ownership of quality systems, including change control, CAPA, and document management, with accountability for process improvement and regulatory alignment.
• Other duties/responsibilities as assigned.

Education, Experience, and Skills

• BS/BA in life sciences.
• 5+ years of quality assurance experience in a regulated manufacturing environment; pharmaceutical or related industry experience is highly preferred.
• Strong communication skills and demonstrated proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Ability to effectively present information in one‑on‑one, small groups, and company meetings.
• Proficiency in applying mathematical and scientific techniques to compile and analyze data.
• Familiarity with eQMS functionality; experience implementing an eQMS is highly desirable.

Working Environment and Travel

While performing the duties of this job, the employee regularly walks, stands, and sits, and must regularly lift and/or move up to 10 pounds. Specific vision abilities required include close vision, peripheral vision, and the ability to adjust focus. Normal office environment with some exposure to lab areas; noise level usually moderate. Occasional travel may also be expected, as needed.

ADA

The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non‑disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets.