Quality Assurance Specialist — GMP Mastery | Flexible Hours

FP Labs; Chanhassen, Northern (MN, KY); Hybrid; USD 62,000 - 77,000; Full time

Benefits offered by this job

Comprehensive Benefits Package

401(k) with company contributions

Generous PTO & Leave

Flexible Scheduling

Education Reimbursement Program

Culture that values you

Job summary

FP Labs is seeking a Quality Assurance Specialist to join our team in Chanhassen, MN. The role focuses on ensuring product quality on the production floor, reviewing batch records, and maintaining QA documentation.

You will lead investigations, CAPAs, and MRB activities while collaborating with cross‑functional teams to uphold regulatory compliance. You will perform daily inspections, coach QA technicians, and help drive continuous improvement in a fast‑paced manufacturing environment.

Qualifications

• 4-5 years of quality assurance or quality control experience in regulated manufacturing.
• Associate or technical degree preferred.
• Strong understanding of GMP, GDP, and regulatory compliance requirements.
• Experience with quality investigations, root cause analysis, deviations, CAPAs, and technical documentation.
• Strong attention to detail, analytical skills, and problem‑solving abilities.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and comprehend English to interpret procedures, complete documentation, and communicate quality requirements effectively.
• Ability to prioritize tasks, work independently, and manage competing demands in a fast‑paced environment.
• Ability to train, coach, and collaborate effectively across departments.
• Proficiency in Microsoft Office, including Word and Excel.
• Familiarity with inspection and measurement equipment.

Responsibilities

• Serve as a primary point of contact for quality-related questions and production floor issues.
• Educate and coach QA Technicians and production employees on compliance, product quality, accountability, and adherence to established procedures.
• Promote a strong culture of quality and continuous improvement by helping prevent recurring issues, reduce defects, and strengthen processes.
• Serve as the QA representative on the production floor when the QA Supervisor is unavailable, collaborating with cross-functional teams to identify, correct, and prevent quality issues.
• Maintain a comprehensive understanding of QA Technician responsibilities and provide hands‑on backup support across QA functions as needed.
• Perform daily finished goods inspections, evaluating approximately 35-40 pallets per day for quality, packaging, labeling, and lot coding accuracy.
• Document inspection results and quality findings in the company's ERP system.
• Review batch records for accuracy, completeness, and compliance with established procedures.
• Identify, document, and manage nonconforming materials, deviations, and required corrective actions.
• Develop, review, and maintain technical quality documentation, including SOPs, work instructions, investigation reports, nonconformance reports, deviations, and CAPA documentation.
• Support root cause investigations, audits, change controls, and MRB activities.
• Provide backup support for label and artwork reviews, assembly inspections, and filling line signoffs.
• Track and trend quality metrics to identify recurring issues and recommend improvements.

Skills

Quality assurance

Regulated manufacturing

GMP/GDP compliance

Root cause analysis

Documentation

Communication skills

English proficiency

Education

Associate or technical degree

Tools

Microsoft Word

Microsoft Excel

ERP system

Job description

FP Labs is seeking a Quality Assurance Specialist to join our team in Chanhassen, MN. The role focuses on ensuring product quality on the production floor, reviewing batch records, and maintaining QA documentation.

You will lead investigations, CAPAs, and MRB activities while collaborating with cross‑functional teams to uphold regulatory compliance. You will perform daily inspections, coach QA technicians, and help drive continuous improvement in a fast‑paced manufacturing environment.