Join Our Team at Oral BioTech as a Quality Assurance Specialist Are you passionate about making a meaningful impact and supporting innovative dental products that improve lives? At Oral Biotech we manufacture a full line of mouthwash and toothpaste where we are committed to advancing oral health through evidence-based solutions that make a real difference for dentists and their patients. Quality Assurance Specialist Role As our Quality Assurance Specialist, you will provide quality assurance support across manufacturing and Quality operations. Your work will include reviewing batch production and quality records, supporting internal audits, and assisting with deviations, CAPAs, change controls, and vendor qualification activities. Working closely with the Quality and Production teams, you will also support validation and equipment qualification activities, document control, and the continued implementation and management of our electronic Quality Management System (eQMS). You will contribute to risk assessments, contamination control programs, and continuous improvement efforts throughout the organization. Success in this position requires strong analytical and technical writing skills, attention to detail, and the ability to effectively manage documentation in a regulated manufacturing environment. The ideal candidate will have experience working within cGMP requirements, be comfortable identifying discrepancies and gathering information, and bring a collaborative approach to problem-solving. They will also demonstrate a commitment to quality and continuous improvement. Company Overview At Oral BioTech, we're more than a company—we're a collaborative team driven by integrity, growth, and continuous improvement. Here, you'll have the opportunity to work cross-functionally, make an immediate operational impact, and grow your career in a mission-driven organization that values our three pillars: Trust, Compassion, and Education. Our foundation is built on three core pillars:

Trusted:

We create and maintain positive relationships through transparency and integrity, establishing trust through our commitment to provide quality service and science-backed products.​​

Compassionate:

We understand oral health complexity and recognize the difficulties clinicians and patients experience. By listening to their needs, we deliver a treatment model to improve people's lives using pH targeted products.​​

Education-Focused:

We foster partnerships by engaging and educating people on effective oral health and wellness strategies.​​

What We Offer:

In addition to a culture of collaboration and growth, we provide: Competitive compensation Comprehensive benefits (Medical, Vision, Dental, and Life Insurance) Work-life balance 11 Paid Holidays Profit-sharing bonus Vacation and sick time IRA with an employer contribution If you thrive in a dynamic and collaborative environment, enjoy problem-solving, and are ready to grow with a team that's making a difference, we want to hear from you. Together, we can ensure Oral BioTech continues to deliver trusted, compassionate, and innovative solutions that improve lives.

Job Summary:

The Quality Assurance Specialist supports day-to-day quality activities and continuous improvement efforts to ensure compliance with current Good Manufacturing Practices (cGMP), company procedures, and applicable regulatory requirements. This position supports internal audits, quality record reviews, deviation/CAPA/change control activities, validation execution, and ongoing eQMS management.

Duties/Responsibilities:

Support manufacturing operations and develop an understanding of company processes and procedures. Assist and conduct routine internal facility audits using a structured audit template. Support vendor qualification program by reviewing supplier questionnaires, quality agreements, supporting documentation, and administrative tasks. Support validations with hands-on protocol execution and summarize results into final reports. Review and disposition batch production records as assigned. Review and approve Quality records and manufacturing records as assigned. Support deviation, CAPA, and change control activities as assigned. Create and approve C of A's as required. Assist with document control and training program implementation into an electronic Quality Management System (eQMS). Support continuous improvement activities as identified. Support risk assessments, such as FMEAs, as applicable. Support the development and implementation of contamination control programs, including Environmental Monitoring, Performance Qualification and routine environmental monitoring. Assist and support process validation protocols and final reports. Assist and support equipment qualification and requalification protocols and reports, including Installation, Operational, and Performance Qualification. Support documentation and execution of change controls as part of a cross-functional team. Required Skills and Abilities 2 years of Quality Assurance experience within a cGMP or equivalent regulated environment. Demonstrated experience in technical writing. Ability to don PPE and work in a cleanroom environment. Willingness to learn, grow, and adapt as knowledge and experience develop. Ability to ask questions, gather information, and communicate effectively. Ability to think analytically, spot discrepancies, and brainstorm potential solutions. Excellent attention to detail and precision when filling out documentation, checking records for errors, and filing. Access to reliable transportation between Oral BioTech locations. Ability to manage and prioritize tasks and complete assignments in a timely manner. Comfortable dedicating extended periods to focused, detail-oriented work. Commitment to quality, integrity, company procedures, and regulatory requirements. Preferred Qualifications Experience participating in internal or external audits. Experience in risk assessments, including FMEA. Experience conducting and analyzing root cause analysis. Understanding of regulatory requirements, including familiarity with 21CFR210 and 21CFR211. Experience in a pharmaceutical Quality or manufacturing environment. Physical Requirements Ability to sit or stand for extended periods. Ability to lift up to 25 pounds and occasionally 50 as needed. Occasional bending, stooping, kneeling, reaching, and walking in laboratory and manufacturing areas.

Pay:

$24.00 - $25.00 per hour

Benefits:

Dental insurance Health insurance Life insurance Paid time off Parental leave Retirement plan Vision insurance Application Question(s): Please describe your experience working with quality systems in a regulated environment. Include any experience you have with batch record review, deviations, CAPAs, change controls, audits, validations, or an electronic Quality Management System (eQMS).

Experience:

Quality Assurance:

2 years (Required)

Work Location:

In person