Quality Systems Specialist

SAB BIO; Sioux Falls (SD); On-site; USD 70,000 - 90,000; Full time

Job summary

SAB BIO, located in Sioux Falls, South Dakota, is seeking a Quality Management System (QMS) Specialist. This role focuses on maintaining and improving the quality management system to comply with Good Manufacturing Practices (cGMP) and regulatory requirements in a biotech environment.

The ideal candidate will have a BS/BA in life sciences and 2–5 years of experience in quality assurance roles. Key responsibilities include supporting quality systems, document control, and ensuring data integrity. The position promotes a collaborative and risk-based quality culture.

Qualifications

• 2–5 years of experience in a quality assurance/quality control role in GMP environment.
• Experience with leading deviation investigations and CAPA.
• Must demonstrate strong communication skills.

Responsibilities

• Facilitate implementation of GxP computerized systems.
• Ensure systems are compliant and validated.
• Promote a proactive, risk-based quality culture.

Skills

Quality Management Systems (QMS)

Document control

Root cause analysis

Quality risk management

Cross-functional collaboration

Microsoft Office software

Education

BS/BA in life sciences or related field

Job description

The Quality Management System (QMS) Specialist is responsible for the administration, maintenance, and continuous improvement of the company’s Quality Management System to ensure compliance with current Good Manufacturing Practices (cGMP) and global regulatory requirements in a biotech environment.

This role has a strong focus on quality systems and technology platforms, supporting business units in the implementation, integration, and maintenance of GxP-relevant systems. The specialist collaborates cross-functionally with Quality, IT, and operational teams to ensure systems are compliant, validated as required, and effectively supporting business processes.

The role supports and drives quality system processes including document control, training, change control, deviations, and CAPA, while ensuring data integrity, system effectiveness, and inspection readiness. This position promotes a proactive, risk-based quality culture aligned with regulatory expectations and industry best practices.

Responsibilities

• Facilitate implementation, validation, and lifecycle management of GxP computerized systems, including eQMS and related quality platforms
• Partner cross-functionally with IT and system owners to ensure systems are configured, maintained, and controlled in compliance with internal procedures and regulatory expectations (e.g., 21 CFR Part 11, Annex 11)
• Provide system-related support to business units, including troubleshooting, user guidance, and continuous improvement initiatives
• Ensure data integrity principles (ALCOA+) are applied within quality systems and supported across system workflows
• Participate in system upgrades, changes, and integrations, ensuring appropriate change control, validation, and risk assessment activities are executed
• Actively promote a proactive, risk-based quality culture aligned with regulatory expectations and industry best practices

Supervisory Duties

This position does not have supervisory responsibilities.

Education / Experience / Skills

• BS/BA in life sciences or related field required
• Minimum of 2–5 years of experience in a quality assurance/quality control role within a regulated (GMP) environment
• Demonstrated level of experience and proficiency with Quality Management Systems (QMS, LIMS, EMS, FMS) is required
• Experience with document control, leading deviation investigations, leading CAPA, and leading change control
• Understanding of cGMP requirements and applicable regulatory expectations (FDA, EMA, etc.)
• Strong knowledge of root cause analysis and quality risk management principles (ICH Q9)
• Must have strong communication and cross-functional collaboration skills
• Demonstrated proficiency in Microsoft Office software (Word, Excel, PowerPoint, Outlook)
• Ability to analyze and trend data to support quality system improvements

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.

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