Quality Assurance Specialist

FP Labs

Chanhassen, Northern (MN, KY)

Hybrid

USD 62,000 - 77,000

Full time

5 days ago
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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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Assurance Specialist

Full Time Regular Manual Labor Chanhassen, MN, US

2 days ago Requisition ID: 1220

$30.00 To $37.00 Hourly

Who You Are

You are a detail-oriented quality professional with experience in regulated manufacturing and a strong understanding of quality systems, documentation, and compliance. You thrive in fast-paced environments, effectively manage multiple priorities, and adapt to changing operational needs. You are comfortable working on the production floor, investigating quality issues, and partnering with cross-functional teams to maintain product quality and drive continuous improvement.

What You'll Do
  • Serve as a primary point of contact for quality-related questions and production floor issues, providing technical guidance and escalating complex concerns to QA management as needed.
  • 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 Material Review Board (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.
What You Bring
  • 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.
Physical Demands
  • Vision Requirements: Ability to perform tasks involving close vision, distance vision, color vision, peripheral vision, depth perception, and adjustment of focus.
  • Color Differentiation: Ability to visually compare colors against established reference standards, including standard color solutions or approved reference materials. Ability to accurately identify color‑coded labels, status tags, and chemical hazard warnings within the work environment.
  • Sensory Evaluation (Odor Detection): Ability to detect and differentiate odors during the evaluation of raw materials and finished products in accordance with applicable USP monographs and/or internal testing specifications. This includes identifying unexpected or out‑of‑specification (OOS) odors that may indicate contamination, degradation, or spoilage.
  • Material/Product Appearance Evaluation: Ability to visually evaluate the appearance of raw materials and finished products as required by applicable USP monographs and internal testing specifications, including identifying irregularities or deviations from established standards.
Why Federal Package?

As we continue to grow, we're actively investing in our people, our technology, and our future. That means this is the perfect time to join our team and make your mark. You'll have the opportunity to contribute meaningfully, take ownership of your work, and help shape the direction of our organization. Whether you're passionate about innovation, leadership, or operational excellence, there's room to grow here.

At Federal Package, we believe that you work your best when you feel your best. Here is what you can expect from us:

  • Comprehensive Benefits Package:Medical, dental, vision, life insurance, and disability coverage.
  • Retirement Support:401(k) with company contributions to help you plan for your future.
  • Generous PTO & Leave:Paid time off, volunteer time, bereavement leave, and new parent paid leave.
  • Flexible Scheduling:Flex time and support for work‑life balance.
  • Education Reimbursement Program:We invest in your continued personal and professional development.
  • A Culture That Values You:Your energy, ideas, and ambition will be recognized and rewarded.
Schedule

Monday-Friday, with one of the following shifts:

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