Quality Assurance Associate I

Solvias Group; Canton (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

Solvias Group is seeking an entry-level Quality Assurance professional in Canton, Massachusetts. This role will involve assisting with training organization, SOP drafting, compliance verification, and internal audits related to cGMP and GLP standards. The ideal candidate must be able to support quality system functions and undertake various projects as assigned by management. This is an excellent opportunity to start a career in quality assurance within a supportive environment.

Qualifications

• Entry level quality assurance experience.
• Familiarity with cGMP and GLP regulations.
• Ability to assist with training and audits.

Responsibilities

• Assist with training organization and implementation.
• Help draft/edit SOPs and protocols.
• Conduct internal and external facility audits.

Job description

Position Overview

An entry level quality assurance position. Responsibilities include, but are not limited to: assisting with the organization and implementation of training for employees; assisting with SOP/Protocol drafting/editing/routing; creation and completion of cGMP/GLP records and archival activities; and assisting QAU Management with internal and external facility audits as well as audit R&D, cGMP and GLP data as applicable. An employee in this position will be expected, when fully trained, to assist with the verification that the facility and records are in compliance with appropriate regulatory requirements – including US FDA Good Laboratory Practices (GLP) and US FDA current Good Manufacturing Practices (cGMP) – and to provide back‑up support to all quality system functions as necessary. This position may also have additional projects as directed by QAU Management.