Quality Assurance Specialist

Medix™; Waunakee (WI); On-site; USD 60,000 - 85,000; Full time

Job summary

A leading healthcare staffing company is looking for an Operations On‑Site QA Specialist to join their team in Waunakee, Wisconsin. The role involves conducting on-site QA operations, supporting manufacturing processes, and ensuring compliance with quality standards. Ideal candidates will have experience in a cGMP QA setting and be prepared to work in a fast-paced environment. This is a full-time position offering a competitive salary range from $60,000 to $85,000 a year.

Qualifications

• Prior experience in a cGMP QA setting.
• Ability to conduct on the floor reviews of manufacturing and testing operations.
• Experience in identifying and evaluating facility events.

Responsibilities

• Learn the process and perform functions independently.
• Conduct on the floor reviews of all manufacturing and testing operations.
• Support the document control team in issuing records as needed.

Skills

cGMP QA experience

Document verification

On-site QA operations

Job description

This range is provided by Medix™. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base Pay Range

$60,000.00/yr - $85,000.00/yr

Operations On‑Site QA Specialist

• Will be introduced to the on‑site QA department and associated functions and responsibilities. The individual will have prior experience in a cGMP QA setting similar to the items outlined below. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently. It is the expectation that the Operations On‑Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below.
• Conducts on the floor reviews of all manufacturing and testing operations.
• Performs verifications required to support manufacturing and testing documentation (including but not limited to batch records, cleaning records, logbooks, and test methods).
• Assists all departments in the identification and evaluation of facility events.
• Performs on the floor reviews of executed batch records.
• Assists in the organization and/or the establishment/maintenance of relevant procedures/documents.
• Assists in audits where necessary.
• Supports the document control team in issuing records as needed.
• Performs other duties as assigned.

Seniority Level

Associate

Employment Type

Full‑time

Job Function

Quality Assurance (Pharmaceutical Manufacturing)