Quality Systems Specialist
Sioux Falls, SD
Full Time
Experienced
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.
Duties and Responsibilities (Responsibilities include but are not limited to):
This position does not have supervisory responsibilities.
Education/Experience/Skills:
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
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.
Duties and Responsibilities (Responsibilities include but are not limited to):
- 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.
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.
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
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