Senior Quality Assurance Specialist

SAB; Sioux Falls (SD); On-site; USD 85,000 - 120,000; 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 in a biotech environment. With 5+ years of QA experience, you will manage investigations, change control, CAPA, and support regulatory inspections, while mentoring junior staff.

The role requires strong communication, data analysis, and proficiency with eQMS and MS Office. This onsite position offers relocation assistance and opportunities for cross-functional collaboration to uphold product quality and

Qualifications

• 5+ years of quality assurance experience in a regulated manufacturing environment.
• Strong communication skills and ability to present to leadership.
• Experience with quality systems and CAPA/change control.
• Experience with eQMS is highly desirable.
• Proficient in MS Office.

Responsibilities

• Lead and oversee quality oversight of manufacturing and QC operations, including batch record review and deviation investigations.
• Independently lead quality-driven projects and present metrics and validation reviews to leadership.
• Drive ownership of quality systems, including change control, CAPA, and document management.
• Other duties/responsibilities as assigned.

Skills

Quality Assurance

Regulatory Compliance

Communication Skills

Data Analysis

MS Office

Education

BS/BA in life sciences

Tools

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.

Note: 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.
• Must have strong communication skills. Demonstrated proficiency in Microsoft Office software (Word, Excel, PowerPoint and Outlook).
• Ability to effectively present information in one-on-one, small groups and company meetings.
• Utilizes established mathematical and scientific techniques to compile and analyze data.
• Familiar with eQMS functionality. Experience implementing an eQMS is highly desirable.

Working Environment and Travel

While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must regularly lift and/or move up to 10 pounds. Specific vision abilities required by this job include 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.

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.

This job description will be reviewed periodically as duties and responsibilities change with business necessity. Primary and additional duties and responsibilities are subject to modification.

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 identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets