Quality Assurance Associate I

Position Overview

An entry level quality assurance position.

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
• When fully trained, assisting 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)
• Auxiliary support to all quality system functions as necessary
• Performing audit of cGMP/GLP (and R&D as required) analytical data packages for compliance with cGMP/GLP regulations
• Ensuring that work conforms to appropriate regulatory requirements, including SOPs, US FDA Good Laboratory Practices (GLP) and US FDA current Good Manufacturing Practices (cGMP)

Qualifications

• Bachelor's degree in a scientific area of study related to pharmaceutical contract analytical methodology is preferred
• Experience of up to 3 years in a regulated environment is encouraged, but not required

Essential Job Functions

• Exhibit a basic understanding of analytical chemistry and regulatory compliance pertinent to the work being completed
• Track, file and secure all controlled documents and records in the QAU document control system and auditing technically approved raw data and documentation associated with analytical testing and facility compliance with adherence to cGMP regulations
• Effectively interact with management, senior staff members, co-workers and external contacts
• Strict adherence to Solvias USA, LLC Safety Program

Requirements

• BA/BS degree in a scientific area of study related to pharmaceutical contract analytical methodology is preferred
• Experience of up to 3 years in a regulated environment is encouraged, but not required
• Other Desired Skills/Abilities: Ability to work in a team environment where timely delivery is essential and shifting priorities can be expected; Familiarity with Microsoft products such as Word, Excel, PowerPoint, Outlook, Access, and Teams; Strong written and verbal communication skills and attention to detail

Reporting Structure

This Job Typically Reports To Manager, Quality Assurance Unit and/or Senior Manager, Quality Assurance Unit

About Us

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. Headquarters are located near Basel, Switzerland, with six global Centers of Excellence adhering to the highest ISO, GMP, GLP, and FDA standards.