In-Process Quality Compliance Specialist (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

Role SnapshotBe the on-site compliance partner at Scientific Protein Laboratories (SPL)—a global leader in biosourced pharmaceuticals and cGMP API manufacturing based in Waunakee, WI (near Madison). As an In-Process Quality Compliance Specialist, you’ll ensure manufacturing and QC testing activities meet cGMP and documentation standards in real time.What You’ll DoObserve 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.Assist departments in identifying and evaluating facility events.Help organize, establish, and maintain procedures and controlled documentation.Participate in audits as needed.Support Document Control in issuing records (e.g., via Master Control and our eQMS).Where You’ll WorkLocation: Waunakee, Wisconsin (just outside Madison)Shifts: 1st and 3rd shift openings availableHow You’ll Ramp UpYou’ll operate with minimal supervision from senior team members. With guidance from management, you will learn the processes and steps needed to independently execute all on-site QA duties. Prior cGMP QA experience is expected.What You BringWe welcome applicants across a spectrum of experience. If you meet the minimum criteria, please apply. Final job level and compensation will reflect your education, experience, skills, and overall qualifications.Required: Bachelor’s degree in a scientific field, or 2+ years of QA experience in a regulated industry.Preferred: Bachelor’s degree in a scientific field plus 5+ years of QA experience in a regulated industry.Proficiencies & SystemsGood Manufacturing Practices (GMP)Batch records, cleaning records, logbooksQuality Assurance (QA) fundamentalsTest methodseQMS, Master Control, Document ControlBenefits & CultureCompetitive compensationMedical, Dental, Vision starting Day 1Life and AD&D InsuranceShort- and Long-term DisabilityHealth and Flexible Spending AccountsEmployee Assistance ProgramGenerous vacation and paid Holidays401k and advancement opportunitiesTeam-oriented environment, community involvement, and company eventsAbout SPLFor over four decades, SPL has delivered unique products and services that support the global pharmaceutical industry, specializing in cGMP-compliant API development and manufacturing.Equal OpportunitySPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.