Quality Assurance Associate
Listed on 2026-07-01
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist, Data Analyst
Quality Assurance 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.
Critical Performance Areas
Essential Job Functions
- Exhibit a basic understanding of analytical chemistry and regulatory compliance pertinent to the work being completed.
- Responsible for tracking, filing and securing 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
NOTE:
This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.
Disclaimer:
Solvias USA, LLC does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.
This role is budgeted for a base salary cap of $70,000.
About UsSolvias 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
Job Info- Job Identification 172
- Locations 480 Neponset Street, Canton, Massachusetts, 2021, US
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).