Quality Assurance Associate I

Solvias • Canton, MA

4d

About The Position

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.

Solvias is a global provider of chemistry, manufacturing, and control (CMC)
analytics to the life sciences industry. Our expert team combines decades of
experience with regulatory expertise across small molecules, biologics, and cell
and gene therapies. Solvias offers end-to-end solutions from raw material
testing to drug product release and API development for small molecules.
Headquartered near Basel, Switzerland, Solvias operates six global Centers of
Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards

Responsibilities

• 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
• Assisting QAU Management with internal and external facility audits as well as audit R&D, cGMP and GLP data as applicable
• 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)
• Provide back-up support to all quality system functions as necessary
• Additional projects as directed by QAU Management

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed