What are the responsibilities and job description for the Quality Assurance Specialist position at SAB?
The Quality Assurance (QA) Specialist ensures compliance with GMP and regulatory requirements within a biotech manufacturing environment. With over two years of industry experience, this role supports batch record review, deviation investigations, change control, CAPA, and internal audits. The specialist collaborates cross-functionally to maintain and improve quality systems, ensuring consistent product quality and regulatory readiness.
Responsibilities:
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.
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.
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
Responsibilities:
- Lead and support quality investigations by gathering data, performing root cause analysis, and documenting findings and CAPAs to resolve deviations, nonconformances, or complaints.
- Independently review and manage change control records to ensure changes to processes, equipment, or documents are properly assessed, justified, approved, and implemented in accordance with quality procedures.
- Participate in internal and external audits by preparing documentation, supporting audit execution, and tracking corrective actions to ensure compliance with regulatory and quality standards.
- Perform document management activities including revision control and archival, review batch records and supporting documentation for accuracy and compliance and assess raw material release packages to ensure specifications and quality requirements are met prior to use.
- Other duties/responsibilities as assigned
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BS/BA in life sciences, with a minimum of 2 years of quality assurance experience in a regulated manufacturing environment.
- Associate of Science degree is acceptable with an additional 2 years of experience in a regulated manufacturing environment.
- Must have strong communication skills. Must be proficient in Microsoft Office software (Word, Excel, PowerPoint and Outlook). Ability to effectively present information in one-on-one, small groups and lab meetings.
- Utilizes established mathematical and scientific techniques to compile and analyze data.
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.
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.
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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