Quality Systems QA Manager: GMP Compliance & Improvements

Scientific Protein Laboratories; Waunakee (WI); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive benefits

Medical/Dental/Vision Day 1

Life and AD&D Insurance

Short/Long-term Disability

Health Savings Account

Employee Assistance Program

Vacation

401k

Career advancement

Team environment

Community involvement

Company events

Job summary

Scientific Protein Laboratories in Waunakee, WI is seeking an experienced Quality leader to oversee the Quality System, investigations, CAPAs, and document control. This role drives continual improvement, ensures GMP compliance, and coordinates internal and external audits and product releases.

The ideal candidate has 10+ years in quality with a preference for 15+ years, and a Bachelor's degree or higher. Excellent benefits and a collaborative team environment are offered.

Qualifications

• Associate's or bachelor's degree preferred.
• 10+ years of relevant quality experience; 15+ years preferred.

Responsibilities

• Oversee Quality System functions, including training, investigations, deviations, change controls, CAPAs and validation/qualification docs.
• Maintain/establish procedures and documents.
• Report and communicate Quality System metrics to management.
• Administer the electronic quality management system (eQMS).
• Lead cGMP quality system improvements to meet FDA/ICH/ISPE standards.
• Oversee external audits and responses to findings.
• Perform intermediate and finished product release and shipping documentation review/approval.
• Prepare Annual Product Review reports for SPL products.
• Draft and verify customer quality agreements and ensure SPL compliance.
• Investigate process deviations and customer complaints with proper documentation.
• Participate in Material Review Board and address customer communications.

Skills

Quality system

Training coordination

Investigations

CAPA management

eQMS

Education

Associate's degree

Bachelor's degree or higher

Tools

eQMS software

Job description

Scientific Protein Laboratories in Waunakee, WI is seeking an experienced Quality leader to oversee the Quality System, investigations, CAPAs, and document control. This role drives continual improvement, ensures GMP compliance, and coordinates internal and external audits and product releases.

The ideal candidate has 10+ years in quality with a preference for 15+ years, and a Bachelor's degree or higher. Excellent benefits and a collaborative team environment are offered.