Quality Systems QA Manager

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

Job DetailsJob Location: Scientific Protein Laboratories - Waunakee, WI 53597Position Summary

Responsibilities Include:

• Responsible for the functions associated with the Quality System, including oversight and coordination of training, investigations (including customer complaints), deviations, change controls, CAPAs and validation/qualification documents.
• Oversee the establishment/maintenance of relevant procedures/documents
• Compiles and communicates metrics associated with the Quality System to management as required.
• Administer and oversee the electronic quality management system (eQMS).
• Responsible for continuous improvement of SPL cGMP Quality Systems to support compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.
• Oversee external agency and customer audits, and responses to audit findings.
• Performs intermediate and finished product release, and shipping documentation review/approval.
• Responsible for the prompt, technically accurate and cGMP-compliant preparation of Annual Product Review documentation for all SPL Marketed Products.
• Writes customer related Quality Agreements and verifies SPL is compliant with the approved Quality Agreements (including customer notifications)
• Oversee the investigation of process deviations, product failures, customer complaints or facility incidents and assures proper documentation and investigation per established procedures. Approves minor deviations and related CAPAs.
• Participates in the Material Review Board including assessment of customer complaints. Participates in assigning and addressing all customer communications.

Requirements:

• Associate's Degree, Bachelor's Degree or above preferred
• 10+ years of experience, 15+ years preferred

WHY JOIN SPL?

Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

Perks include:

• competitive compensation
• excellent benefits package - including Medical, Dental and Vision on Day 1
• Life and AD&D Insurance, and Short and Long-term Disability
• Health and Flexible Saving Account options
• Employee Assistance Program, generous vacation
• paid Holidays
• 401k
• advancement opportunities
• team-oriented environment
• community involvement
• company events and more!

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.