Senior QA Specialist: Recalls, Audits & Compliance

Cardinal Health; Madison (WI); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

Health savings account

401k plan

Wages on demand

FSAs

Disability insurance

Work-Life resources

Parental leave

Wellness programs

Job summary

Cardinal Health is seeking a Senior Specialist, Quality Assurance to execute quality programs and procedures in a specialty area such as recalls and customer complaints. You will support audits, develop insights, and mentor junior specialists while helping lead SOP development under the Manager's guidance.

With experience in GMP and manufacturing, you will drive compliance, track metrics, and collaborate with stakeholders to ensure products meet regulatory standards and quality expectations

Qualifications

• 2-4 years of experience, preferred.
• BA, BS or equivalent education and experience combination in related field preferred.
• Combination of GMP experience and manufacturing experience.
• Comprehensive knowledge of cGMPs, 21 CFR 11, 210, 211 and 820.
• Proficient with electronic quality management systems; Veeva Vault is a plus.
• Familiarity with pharmaceutical manufacturing and packaging processes, equipment and facilities.

Responsibilities

• Ensures fulfillment of external reporting requirements related to area of specialty, such as recalls; submits reports for internal review prior to regulatory submission.
• Apply knowledge of GMP regulations and manufacturing processes to drive compliance, support operational excellence, and mitigate risk.
• Customer Complaint Investigations
• Supporting Monthly Metrics
• Authors or updates standard operating procedures
• Executes internal programs to define Quality guidelines and track adherence to these guidelines; guides internal stakeholders on QA policies
• Responds to significant quality issues; conducts root cause analyses and reports on metrics and trends
• Supports the Change Control Program by assessing QA implications of changes
• Updates SOPs in response to product changes and regulatory developments
• Prepares responses to regulatory queries, audits and corporate audits with stakeholders
• Supports QA in audits and inspections of distribution centers; drafts reports and insights for leadership
• Guides junior Specialists and assists with onboarding trainings; reviews work prior to delivery to Manager

Skills

GMP knowledge

Quality systems familiarity

Regulatory compliance

Education

BA/BS or equivalent

Tools

Veeva Vault

eQMS

Job description

Cardinal Health is seeking a Senior Specialist, Quality Assurance to execute quality programs and procedures in a specialty area such as recalls and customer complaints. You will support audits, develop insights, and mentor junior specialists while helping lead SOP development under the Manager's guidance.

With experience in GMP and manufacturing, you will drive compliance, track metrics, and collaborate with stakeholders to ensure products meet regulatory standards and quality expectations