Onsite QA Compliance Specialist — cGMP Biopharma APIs

SPL Biopharma; Waunakee (WI); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental, Vision starting Day 1

Life and AD&D Insurance

Short- and Long-term Disability

Health and Flexible Spending Accounts

401k and advancement opportunities

Generous vacation and paid Holidays

Employee Assistance Program

Job summary

Scientific Protein Laboratories (SPL) is seeking an on-site In-Process Quality Compliance Specialist at our Waunakee, WI facility. You will ensure manufacturing and QC testing activities meet cGMP standards and program documentation in real time.

You will observe floor operations, verify batch records, cleaning records, logbooks, and test methods, and assist in evaluating facility events. The role involves audits and maintaining controlled documentation with our eQMS and Master Control systems.

Qualifications

• Bachelor’s degree in a scientific field or 2+ years of QA experience in a regulated industry.
• Prior cGMP QA experience is preferred.
• Proficiencies: Batch records, cleaning records, logbooks, and test methods; familiarity with eQMS, Master Control, and Document Control.

Responsibilities

• Observe and review on-the-floor manufacturing and testing operations.
• Verify documentation accuracy: batch records, cleaning records, logbooks, and test methods.
• Review executed batch records directly on the floor and assist in identifying facility events.
• Support document control in issuing records and participate in audits as needed.

Skills

GMP knowledge

Documentation review

On-floor observation

Education

Bachelor’s degree in a scientific field

2+ years QA experience in regulated industry

Tools

eQMS

Master Control

Document Control

Job description

Scientific Protein Laboratories (SPL) is seeking an on-site In-Process Quality Compliance Specialist at our Waunakee, WI facility. You will ensure manufacturing and QC testing activities meet cGMP standards and program documentation in real time.

You will observe floor operations, verify batch records, cleaning records, logbooks, and test methods, and assist in evaluating facility events. The role involves audits and maintaining controlled documentation with our eQMS and Master Control systems.