QA Supervisor – Regulated Manufacturing Leader

Federal-Package-Network; Chanhassen (MN); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Full benefits package

401(k) with company contributions

Paid time off & leave

Flexible scheduling

Education reimbursement program

Culture that values you

Job summary

Federal Package in Chanhassen, MN seeks a Quality Assurance Supervisor to lead QA operations and ensure compliance with cGMPs, SOPs, and regulatory standards. The role oversees audits, CAPA, deviations, and continuous improvement while guiding a QA team to achieve product quality and efficiency.

Requirements include a Bachelor’s in a science/quality field, 5+ years QA experience in manufacturing, and FDA/ISO audit exposure. Strong leadership and communication are essential.

Qualifications

• Bachelor’s degree in Science, Quality, Engineering, or related field.
• 5+ years of Quality Assurance experience, preferably in manufacturing.
• Experience leading or supervising a team, 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.

Responsibilities

• Supervise and support Quality Assurance Technicians/Inspectors.
• Oversee daily QA operations and serve as the SME and primary escalation point for QA-related issues.
• 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.

Skills

cGMPs knowledge

FDA/ISO audits

CAPA & deviations

Root cause investigations

Leadership/Supervision

Quality systems

Independent decision making

Strong communication

Education

Bachelor’s degree in Science/Quality/Engineering

Job description

Federal Package in Chanhassen, MN seeks a Quality Assurance Supervisor to lead QA operations and ensure compliance with cGMPs, SOPs, and regulatory standards. The role oversees audits, CAPA, deviations, and continuous improvement while guiding a QA team to achieve product quality and efficiency.

Requirements include a Bachelor’s in a science/quality field, 5+ years QA experience in manufacturing, and FDA/ISO audit exposure. Strong leadership and communication are essential.