Lead Specialist QA Quality Systems, Quality - 1st Shift

Scorpion Therapeutics; Town of Vermont (WI); On-site; USD 66,000 - 127,000; Full time

Job summary

Scorpion Therapeutics is seeking a Manager, Quality Systems to lead complex investigations, trend analysis, CAPA proposals, and investigation reporting within a GMP environment.

In this role you will represent QA in deviation triage, facilitate cross-functional problem solving, compile data for reviews and metrics, oversee PQRs and critical complaints, and lead trending assessments. You will also support quality system improvements and assist with audits and inspections.

Qualifications

• BS degree with GMP experience and knowledge of cGMP, Quality Systems, and change control.
• Strong written and spoken communication skills.
• Adept in statistical and mathematical analyses.

Responsibilities

• Lead complex investigations and report investigation data for reviews and metrics.
• Represent QA in deviation triage and facilitate cross-functional problem solving.
• Oversee PQRs and critical complaints and lead trending assessments.
• Support quality system improvements and assist with audits and inspections.

Skills

Strong communication

Technical writing

Statistical analysis

Cross-functional problem solving

Education

BS degree in GMP or related field

Job description

Role: Manager, Quality Systems, responsible for leading complex investigations, trend analysis, CAPA proposals, and investigation reporting within a GMP environment.

Responsibilities

• represent QA in deviation triage
• facilitate cross-functional problem solving
• compile and present investigation data for reviews and metrics
• oversee PQRs and critical complaints
• lead trending assessments
• support quality system improvements
• and assist with audits and inspections

Qualifications

• BS degree with 10+ years’ GMP experience, thorough knowledge of cGMP, Quality Systems, and change control
• strong communication and technical writing skills
• adept in statistical and mathematical analyses

High Value

• GMP
• cGMP standards
• deviation management
• investigation leadership
• CAPA
• trending
• audit support

Work Setup: not specified; salary range $66,000–$127,000 USD.