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Quality Assurance Associate I

Solvias Group
USA
Mid
Discovered 1 months ago

Full Job Posting

Requirements

  • Experience of up to 3 years in a regulated environment is encouraged, but not required.
  • 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
  • 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.

Responsibilities

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

Preferred Qualifications

  • BA/BS degree in a scientific area of study related to pharmaceutical contract analytical methodology is preferred.
  • Other Desired Skills/Abilities

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