Site QA Specialist

Germer International - Pharmaceutical Recruiting; Madison (WI); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Job summary

A recruitment firm in the pharmaceutical sector is seeking a QA Specialist in Madison, WI. This full-time, mid-senior level role requires a Bachelor's degree and at least 2 years of experience in a cGMP setting. The position involves providing quality assurance support, reviewing batch records, and ensuring proper documentation of facility events. Benefits include medical and vision insurance, a 401(k), and paid maternity leave.

Qualifications

• Bachelor's degree or above required.
• 2+ years of experience required in a cGMP setting.
• Experience in quality assurance documentation preferred.

Responsibilities

• Provide QA support independently.
• Assure proper documentation for facility events.
• Review executed batch records.
• Perform inspection and disposition of raw materials.
• Write deviations, investigations, change controls.
• Perform shipping release procedures.
• Assist in preparation of Annual Product Review documentation.

Skills

cGMP experience

Quality Assurance support

Inspection procedures

Document generation for QA

Education

Bachelor's degree or above in Scientific discipline

Job description

Germer International – Pharmaceutical Recruiting provides the following pay range: Base pay range $85,000–$95,000 per year. Actual pay will be based on your skills and experience—talk with your recruiter to learn more.

Manager of Recruiting & Project Management at Germer International

Responsibilities include:

• The 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 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 On‑Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below.
• Assists all departments in the identification and evaluation of facility events. Assures proper documentation is initiated to capture the event.
• Reviews executed batch records.
• Perform inspection and disposition of raw materials on the basis of approved specifications.
• Writes deviations, investigations, change controls and/or CAPAs.
• Performs shipping release procedures.
• Assists in the preparation of Annual Product Review documentation for all SPL Marketed Products.
• Administrative support for the on‑site QA department such as generation of DCR's, file organization, data compilation, training activities, etc.

Job Requirements and Qualifications:

• Education: Bachelor’s degree or above required; Bachelor’s degree or above in Scientific discipline preferred.
• Experience: 2 plus years of experience required; 5 plus years of experience preferred.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Quality Assurance and Manufacturing

Industry

Pharmaceutical Manufacturing

Benefits

• Medical insurance
• Vision insurance
• 401(k)
• Paid maternity leave