Quality Assurance Specialist

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, and we are committed to advancing oral health through evidence based solutions that make a real difference for dentists and their patients.

Quality Assurance Specialist

The Quality Assurance Specialist helps maintain compliance with cGMP and company procedures by working with the Quality and Production teams, and contributes to the continued development and management of our eQMS and quality records. Success in this role depends on strong analytical and technical writing skills, attention to detail, and a collaborative approach in a regulated manufacturing environment.

Oral BioTech Overview

We’re a collaborative team driven by integrity 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.

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, 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 is a key member of the Quality Unit, responsible for ensuring day-to-day compliance with current Good Manufacturing Practices (cGMP), company procedures, and applicable regulatory requirements. This position upholds product quality through audits, record review, and supplier oversight, and supports quality system improvements and projects across the facility. The role requires prior experience with quality management systems and documentation in a regulated manufacturing environment.

Duties/Responsibilities:

• Support manufacturing operations and develop an understanding of company processes and procedures.
• Conduct routine internal facility audits using a structured template, and track findings to closure.
• Review batch production records (BPR) and disposition materials and product as assigned.
• Review and approve quality and manufacturing records for cGMP and procedural compliance.
• Evaluate suppliers: review questionnaires, quality agreements, and supporting documentation for the vendor qualification program.
• Create and approve Certificates of Analysis.
• Support Deviations, CAPAs, and Change Controls as part of cross-functional teams.
• Assist with validation and qualification protocols (process validation, IQ/OQ/PQ) and summarize results in final reports.
• Support risk assessments (FMEA) and contamination control and environmental monitoring programs.
• Help implement and maintain document control and training within eQMS.
• Contribute to continuous improvement initiatives.
• Other duties as assigned.

Required Skills and Abilities

• Working knowledge of cGMP and quality management systems (Deviations, CAPAs, Change Control, Document Control).
• Experience with internal audits using structured templates.
• Experience reviewing and approving quality and manufacturing records, including Certificates of Analysis.
• Experience evaluating suppliers and supporting the vendor qualification program.
• Strong attention to detail, technical writing, and cross-functional collaboration.
• Ability to don PPE and work in a cleanroom environment.
• Respectful when interacting with others, gathering information, and communicating effectively.
• Ability to self-manage and prioritize tasks and complete tasks on time.
• Access to reliable transportation between Oral BioTech locations.

Qualifications

• 2 years of Quality Assurance experience within a cGMP or equivalent regulated environment. Including:
• Experience reviewing batch records and quality documentation.
• Experience participating in internal or external audits.
• Experience investigating quality events and determining root cause.
• General understanding of regulatory requirements, including familiarity with 21 CFR 210 and 211.

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

Salary : $24 - $25