Title QA Associate II
Job Summary

The QA Associate will be responsible for supporting compliance activities for GxP operations. The QA Associate will be responsible for a diverse and challenging set of activities related to setting and maintaining quality standards aligned with FDA cGMP regulations.

 

Work location: Aurora, IL (relocation assistance is not provided)

Responsibilities

Review and approve Deviations, CAPAs, investigations, complaints

Auditing Responsibilities

  • Audit all areas of production for adherence to cGMPs.
  • Perform and participate in internal audits and facility inspections.
  • Support and participate in regulatory audit preparedness and during inspections by regulatory agencies.

Calibrate QA and/or production equipment.

Support QA Associate III in executing cleaning validation, purified water and environmental monitoring programs

Knowledge and Skills

Requires a Bachelor’s degree in any life science, preferably in Chemistry and/or Biology. The various QA Associate II levels require the following experience in a regulated environment in Quality Assurance, Quality Control, Compliance, or Manufacturing with 2 to 4 years’ experience.

The candidate must have training in cGMPs and/or cGxPs and relevant regulatory guidelines. Must be familiar with relevant regulations; formal training and/or advanced courses are preferred. Must have excellent interpersonal skills and the ability to communicate company policies and procedures clearly.

Must have strong organizational and record keeping skills, and the ability to handle multiple projects. Ability to work independently in fast-paced environment with little supervision. Ability to adapt to contact change and work effectively in abstract environment. Candidate must be motivated and detail-oriented. Proficient at mid-level in Microsoft Office applications (Word, Excel, Outlook), data management systems and business related application packages highly desired, plus the ability to learn company used applications.

 

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