Quality Assurance Associate I

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.

Critical Performance Areas

1. Assisting in the review and management of controlled documents (including SOPs, protocols and facility records) to ensure the security and functionality of the documentation system, in addition to the maintenance, distribution, tracking, and archiving of all controlled documents in hard copy and electronic formats as applicable.

2. Conducting daily auditing, inspecting and reporting on quality system functions, and assist in other areas of Quality Assurance on an as-needed basis.

3. Performing audit of cGMP/GLP (and R&D as required) analytical data packages for compliance with cGMP/GLP regulations.

4. Ensuring that work conforms to appropriate regulatory requirements, including SOPs, US FDA Good Laboratory Practices (GLP) and US FDA current Good Manufacturing Practices (cGMP).

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.