QA Specialist I - 2nd Shift

About the role

Participate in quality processes with a focus on record administration and troubleshooting issues in records management. Review, classify, and manage incoming quality system records such as Validations, Batch Records, and Lab Notebooks. Ensure records are compliant with Good Documentation Practices and procedural requirements. Collaborate with submitters to resolve record-related issues and troubleshoot documentation concerns. Prepare files for storage, regulatory submissions, and audits, including scanning and electronic archiving.

Responsibilities

• Review, classify, and manage incoming quality system records (Validations, Batch Records, Lab Notebooks)
• Ensure records comply with Good Documentation Practices and procedural requirements
• Collaborate with submitters to resolve record-related issues and troubleshoot documentation concerns
• Prepare files for storage, regulatory submissions, and audits, including scanning and electronic archiving

Requirements

• High school diploma or GED
• 1 - 3 years of relevant experience in records management or quality assurance
• Knowledge of MS Office applications
• Experience with electronic document control systems
• Ability to work on multiple tasks as part of a team or independently
• Reliable transportation and flexibility to work up to 30% travel

Benefits

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match

Pay

Weekly pay