- Performs audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation
location: Meriden, Connecticut
job type: Contract
salary: $29.27 - 34.44 per hour
work hours: 9 to 5
- Establishes auditing requirements, quality standards and test methods in accordance with FDA and GMP requirements.
- Conducts internal audits of manufacturing processes to ensure compliance.
- Conducts review of change controls, CAPA's, and deviations.
- Reviews document and ensures compliance commitment dates for audit responses.
- Interprets complex, explicit documentation to ensure quality standards and compliance.
- May provide training to new employees.
- Works under only very general supervision.
- Work is reviewed for soundness of judgment and overall adequacy and accuracy.
- Contributes to the completion of organizational projects and goals.
- Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
- Frequent internal company and external contacts.
- Represents organization on specific projects.
- Experience: 3 to 6 years.
- B.S - Technical
- CAPA review
- Audit Response Monitoring and Closure
- Deviation Management
- Root Cause Analysis
skills: SOP, FDA, CAPA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.