Quality Assurance Supervisor — cGMP Leader, Flexible Hours

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

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