Quality Assurance Supervisor

Federal Package Network•Chanhassen, MN

12d•Onsite

About The Position

This role is for a quality-focused leader with experience in a regulated manufacturing environment and a strong understanding of cGMPs, FDA requirements, and quality systems. The ideal candidate is detail-oriented, organized, confident in making independent decisions, and possesses strong communication, critical-thinking, and continuous-improvement skills. This position involves supervising and supporting Quality Assurance Technicians/Inspectors, overseeing daily QA operations, and serving as the subject matter expert and primary escalation point for QA-related issues.

Requirements

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.

Nice To Haves

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, 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.