Quality Assurance Supervisor

FP Labs at Federal Package; Chanhassen (MN); On-site; USD 95,000 - 130,000; 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

Federal Package is seeking a quality-focused leader to guide a QA team in a regulated manufacturing setting. You will supervise QA technicians, act as SME for quality issues, and ensure cGMPs and SOPs are followed across batch records, materials, labels and finished products.

You’ll drive CAPA programs, participate in FDA/ISO audits, and lead continuous improvement initiatives while partnering with Manufacturing, Engineering and Supply Chain to prevent quality problems and ensure product

Qualifications

• Bachelor’s degree in science, quality, engineering or related field.
• 5+ years of Quality Assurance experience in manufacturing.
• Experience leading or supervising a QA team.
• Experience with FDA and/or ISO audits.
• Knowledge of cGMPs, quality systems, CAPA and deviations.
• Experience with internal audits and continuous improvement.
• Strong written and verbal communication and problem-solving skills.

Responsibilities

• Supervise and support Quality Assurance Technicians/Inspectors.
• Oversee daily QA operations and act as SME for QA issues.
• Ensure compliance with cGMPs, SOPs, specs and regulatory requirements.
• Review batch records and manufacturing documentation for accuracy.
• Perform quality audits of raw materials, packaging, labels, and finished products.
• Investigate deviations, complaints, and nonconforming materials; support CAPAs.
• Lead root cause analysis and CAPA development, implementation and effectiveness.
• Participate in internal, FDA, ISO, and customer audits.
• Support IQ, OQ, and PQ validation activities.
• Create and maintain QA SOPs, work instructions and quality programs.
• Train employees on GMPs, quality procedures and expectations.
• Lead continuous improvement initiatives focused on product quality and risk reduction.
• Collaborate with Manufacturing, Engineering, Supply Chain and other teams to resolve quality issues.
• Monitor quality trends and drive proactive quality improvements.

Skills

QA leadership

Regulatory compliance

cGMPs

FDA audits

CAPA & deviations

Root cause analysis

Continuous improvement

Communication

Independent decision making

Six Sigma Green Belt

Education

Bachelor’s degree in Science/Quality/Engineering or related field

Job description

You are a quality-focused leader with experience in a regulated manufacturing environment and a strong understanding of cGMPs, FDA requirements, and quality systems. You are detail-oriented, organized, and confident making independent decisions. You communicate effectively and have the ability to lead, coach, and develop a QA team while applying strong critical-thinking and continuous-improvement skills.

What You’ll Do

• Supervise and support Quality Assurance Technicians/Inspectors.
• Oversee daily QA operations and serve as the SME and primary escalation point for QA-related issues, providing guidance on quality, compliance, regulatory, and product-related matters.
• Ensure compliance with cGMPs, SOPs, specifications, and regulatory requirements.
• Review batch records and manufacturing documentation for accuracy and compliance.
• Perform quality audits of raw materials, packaging, labels, and finished products.
• Investigate deviations, complaints, and nonconforming materials and support CAPAs.
• Oversee root cause analysis and CAPA development, implementation, and effectiveness.
• Participate in internal, FDA, ISO, and customer audits.
• Support IQ, OQ, and PQ validation activities.
• Create and maintain QA SOPs, work instructions, and quality programs.
• Ensure appropriate training on GMPs, quality systems, and applicable regulatory requirements.
• Lead continuous improvement initiatives focused on product quality, compliance, efficiency, and risk reduction.
• Partner with Manufacturing, Engineering, Supply Chain, and other teams to resolve quality issues.
• Monitor quality trends and support proactive quality improvement.
• Train employees on GMPs, quality procedures, and quality expectations.

What You’ll Bring

• Bachelor’s degree in Science, Quality, Engineering, or a related field.
• 5+ years of Quality Assurance experience, preferably in manufacturing.
• Experience leading or supervising a team, either directly or indirectly.
• Experience with FDA and/or ISO audits.
• Knowledge of cGMPs, quality systems, CAPA, deviations, and root cause investigations.
• Experience with internal audits and continuous improvement.
• Strong written, verbal, and interpersonal communication skills.
• Strong attention to detail, organization, and problem-solving skills.
• Ability to confidently make independent decisions.
• Six Sigma Green Belt certification preferred but not required.

Physical Demands

• Vision Requirements: This position requires the ability to perform tasks involving close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Color Differentiation: The role requires the ability to visually compare colors against established reference standards, including standard color solutions or approved reference materials. The position also requires the ability to accurately identify color-coded labels, status tags, and chemical hazard warnings within the work environment.
• Sensory Evaluation (Odor Detection): The position may require the 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: The position requires the 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.