Senior Quality Assurance Specialist
Sioux Falls, SD
Full Time
Mid Level
Some relocation assistance may be available for this role. Onsite role.
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.
Duties and Responsibilities:
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.
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
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.
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.
- Independently lead quality-driven projects and present key quality metrics, training initiatives, and validation documentation reviews to leadership and cross-functional teams.
- Other duties/responsibilities as assigned.
- 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.
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.
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
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