Senior Quality Assurance Specialist
SAB•Sioux Falls, SD
•Onsite
About The Position
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.
Requirements
- BS/BA in life sciences
- 5+ years of quality assurance experience in a regulated manufacturing environment.
- 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.
Nice To Haves
- Pharmaceutical or related industry experience is highly preferred.
- Experience implementing an eQMS is highly desirable.
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.
Benefits
- Relocation assistance
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What This Job Offers
Job Type
Full-time
Career Level
Senior
