Quality Assurance Specialist

Job Summary

This position requires the ability to perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of processes and projects assigned. The Quality Assurance Specialist will provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization.

Duties/Responsibilities

· Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout the facility.

· Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards.

· Ensure compliance to all internal requirements.

· Provide assistance to laboratories with appropriate quality oversight.

· Escalate unplanned events and issues, providing immediate notification to Quality Management, supporting and providing guidance to quality staff as assigned.

· Review Quality documentation including but not limited to review of laboratory reports, CoAs, methods, SOP’s, specifications, method validation protocols and method validation reports.

· Remain proficient and knowledgeable within respective fields of operation in accordance with job responsibility and function, able to troubleshoot process, system, material and technique-related issues.

· Act as QA representative on project teams, providing Quality guidance and support.

· All other duties as assigned.

Required Skills/Abilities

· Critical thinking

· Problem-solving

· Attention to detail

· Curiosity and investigative mindset

· Excellent Verbal and Written communication skills

· Collaborative mindset

Education and Experience

· Bachelor’s degree with 4 years of professional experience in the pharmaceutical/nutraceutical industry, preferably with 2 years in a Quality role or;

· Associate degree with 5 years of professional experience in the pharmaceutical/nutraceutical industry, preferably with 3 years in a Quality role.

· At least 1 year of batch record review and on the floor quality assurance manufacturing support.

Physical Demands

· Position requires the capacity to handle and manipulate objects using hands and arms

· Standing and walking for extended periods while performing in‐process checks or line inspections

· Moving between production rooms, warehouses, and labs throughout the shift

· Occasional climbing of stairs or step stools to inspect equipment or materials

· Reaching, bending, or crouching to access equipment, sampling ports, or packaging lines

· Noise exposure from machinery (typically moderate, with hearing protection available if needed)

· Exposure to:

o Powdered ingredients

o Strong odors from botanicals or extracts