Senior Quality Assurance Specialist

Duties and 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

Education/Experience/Skills

• BS/BA in life sciences
• 5+ years of quality assurance experience in a regulated manufacturing environment. Pharmaceutical or related industry experience is highly preferred
• 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. Experience implementing an eQMS is highly desirable

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.

EEO/AA/Vets

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