Quality Systems QA Manager

Scientific Protein Laboratories LLC; Waunakee (WI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation

Medical, Dental and Vision on Day 1

Life and AD&D Insurance

Short and Long-term Disability

401k

Paid Holidays

Career advancement

Team-oriented environment

Job summary

Scientific Protein Laboratories LLC in Waunakee, WI seeks a Quality Systems Manager to lead cGMP training, investigations (including customer complaints), deviations, change controls and CAPAs. Develops and maintains a cGMP-compliant Quality Management System and oversees release of intermediates and finished products.

The role also hosts audits, approves validation/qualification documents, coordinates training, and drives continuous improvement to satisfy FDA/ICH, USDA and ISPE standards while

Qualifications

• 10+ years in quality systems or QA in pharma (15+ preferred).
• Experience with FDA/ICH, USDA and ISPE standards.
• Proven ability to manage documentation and audits.

Responsibilities

• Oversee cGMP training, investigations, deviations, CAPAs and validation/qualification documents.
• Coordinate procedures and maintain the Quality Management System.
• Compile metrics and manage release of intermediates and finished products.
• Host external audits and customer inspections; ensure timely responses.

Skills

Quality systems management

cGMP training

Investigations & CAPAs

Audit coordination

Education

Associate's or Bachelor's degree or above

Tools

eQMS

Job description

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

Responsible for management of the sites Quality Systems including but not limited to cGMP training, investigations (including customer complaints), deviations, change controls and CAPAs. Develops and maintains cGMP-compliant Quality Management Systems. Responsible for management of SPL's quality compliance throughout SPL which includes operational activities such as: release of intermediate and finished product, review/coordination of investigations (including customer complaints), approval of deviations, change controls, and CAPAs; approval of validation/qualification documents; hosting of external agencies and/or customer audits. The manager is responsible for personnel activities such as: reviews, workload management and coordination of training.

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.