Quality Assurance Associate, Animal

SAb Biotherapeutics, Inc.; South Dakota; On-site; USD 65,000 - 90,000; Full time

Job summary

SAB BIO is seeking a Quality Assurance Associate, Animal to join our QA team in the United States. You will help ensure that all documentation, procedures and protocols in our animal production and drug manufacturing operations meet GACUP, GVCP, GLP and cGMP requirements.

Your duties include performing audits, reviewing records, supporting AAALAC accreditation activities, approving controlled documents, reviewing data for regulatory compliance, and aiding with qualification/validation efforts.

Qualifications

• QA experience in a regulated environment
• Strong verbal and written communication skills
• Proficiency in MS Office applications (Word, Excel, PowerPoint, Outlook)
• Familiar with eQMS functionality
• Ability to compile and analyze data

Responsibilities

• Perform audits and review records to support regulatory compliance.
• Support QA audits and inspections to ensure regulatory compliance.
• Collaborate with other departments on deviations and CAPA activities.
• Review and approve controlled documents for regulatory compliance.
• Review protocols, reports, data for compliance with regulations and good documentation practices.
• Assist with qualification/validation activities.
• Support other QA or internal projects as needed.

Skills

Quality Assurance

Verbal & written communication

Data analysis

Microsoft Office

Education

BS in biological sciences

Tools

eQMS

Job description

The Quality Assurance Associate, Animal is an integral member of SAB’s Quality Assurance (QA) Department contributing to our success by ensuring all documentation, procedures and protocols within our animal production systems and drug manufacturing comply with the appropriate governmental regulations pertaining to Good Animal Care and Use Practices (GACUP), Good Veterinary Clinical Practices (GVCP), Good Laboratory Practices (GLP), and current Good Manufacture Practices (cGMP) compliance.

Duties and Responsibilities (Responsibilities include but are not limited to):

• Supports the animal production system for regulatory compliance by performing audits, reviewing executed records, supporting AAALAC International accreditation and ensuring compliance to GLP and GVCP regulations.
• Support quality system audits and inspections to ensure compliance with applicable regulatory requirements, guidelines and internal procedures.
• Work closely with other applicable departments to ensure compliance to regulations and internal procedures and assist them with deviations and corrective/preventative action plan activities.
• Review (and approve) controlled documents (e.g., SOP’s) for compliance to regulations and internal requirements.
• Review protocols, reports, records and data for compliance with regulations, internal procedures, protocols and good documentation practices.
• Support activities related to qualification/validation of equipment and processes.
• Assist with other projects in the quality department or other internal departments as needed.

This position does not have supervisory responsibilities.

Education/Experience/Skills:

• Bachelor of Science (BS) in biological sciences or related discipline.
• 3+ years of quality assurance experience in a regulated environment. Human or animal pharmaceutical or related industry experience is highly preferred.
• Must have strong verbal and written 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.
• Utilize established mathematical and scientific techniques to compile and analyze data.
• Familiar with eQMS functionality.

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 and animal 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 identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.EOE/AA/Vets