QA Specialist

We are seeking a detail-oriented QA Specialist to join our growing Quality Assurance team. This role is responsible for supporting quality systems, ensuring regulatory compliance, and maintaining high standards across manufacturing and quality operations. The ideal candidate will have experience working in a GMP-regulated environment and a passion for continuous improvement, compliance, and product quality.

This is an excellent opportunity for a quality professional looking to make a meaningful impact within a collaborative organization that values innovation, employee development, and work-life balance.

• Review and approve quality documents, including SOPs, protocols, reports, and other controlled documentation to ensure compliance with regulatory requirements.

• Support investigations, deviations, CAPAs, complaints, and non-conformance activities.

• Assist with the preparation of Annual Product Reviews and regulatory compliance documentation.

• Participate in validation activities and quality system improvement initiatives.

• Support responses to regulatory agency inquiries and audits.

• Conduct and assist with internal, supplier, and quality audits.

• Manage and track change controls across multiple departments.

• Draft validation protocols, equipment calibration documentation, and other quality records.

• Support document management activities within electronic quality systems, including Master Control.

• Develop and maintain food safety plans and food safety-related procedures.

• Monitor compliance metrics and ensure quality processes are properly followed.

• Track testing and validation activities to ensure compliance and accuracy.

• Maintain adherence to company policies, GMP requirements, safety procedures, and regulatory standards.

• Bachelor's degree in Biology, Chemistry, Biochemistry, Microbiology, or another Life Sciences field.

• Minimum of 2 years of Quality Assurance experience within the pharmaceutical, biotechnology, dietary supplement, or other regulated industry.

• Knowledge of GMP and cGMP regulations.

• Experience supporting validation, quality control, or manufacturing quality activities.

• Familiarity with FDA 21 CFR regulations and industry quality standards.

• Strong attention to detail and excellent documentation practices.

• Proficiency with Microsoft Excel and other Microsoft Office applications.

• Ability to work independently while collaborating effectively with cross-functional teams.

• Strong organizational, communication, and problem-solving skills.

• Additional experience within pharmaceutical, biotechnology, or dietary supplement manufacturing environments.

• Experience managing deviations, CAPAs, change controls, and investigations.

• Familiarity with Master Control or other electronic Quality Management Systems (eQMS).

• Knowledge of ICH guidelines and international GMP requirements.

• Experience supporting supplier audits and regulatory inspections.

• Demonstrated ability to improve processes and transition manual systems into electronic workflows.

• Self-starter who embraces change and continuous improvement initiatives.

This position is primarily office-based and works closely with a small, collaborative Quality Assurance team. Employees enjoy a supportive culture focused on professional development, flexibility, and work-life balance. The company offers a highly competitive benefits package, including:

• Comprehensive medical, dental, and vision coverage

• Sign-on bonus opportunities

• Generous PTO with immediate eligibility

• Professional growth and development opportunities

• Collaborative and team-oriented work environment

• Make a direct impact on quality and compliance initiatives.

• Gain exposure to a wide range of quality systems and…