Job Title: Quality SpecialistJob Description
The Quality Specialist will lead and manage the quality function for a small, growing pharmaceutical manufacturing organization. This role establishes, maintains, and continuously improves the Quality Management System (QMS) while ensuring full compliance with FDA and other applicable regulatory requirements. The position is ideal for a hands-on quality assurance professional who can independently manage quality operations, oversee validation activities, support internal and external laboratory operations, and serve as the primary point of contact with regulatory authorities, including the FDA.
Responsibilities

+ Own and administer the company’s Quality Management System (QMS), including standard operating procedures (SOPs), deviations, corrective and preventive actions (CAPAs), change control, complaints, and documentation control.

+ Ensure ongoing compliance with FDA current Good Manufacturing Practice (cGMP) regula...