QA Auditor

About the role

Allied Reliability is seeking QA Auditors for Pharmaceutical Manufacturing. Onsite training is provided in the QA Auditor's job duties.

Responsibilities

• Perform in-house line audits of pharmaceutical filling and packaging operations
• Review manufacturing activities and documentation for compliance with SOPs
• Perform line clearances, in-process, and end-item inspections
• Review and apply specifications for acceptance of in-coming packaging components, raw materials, and finished products
• Generate, review, and issue batch production records
• Release materials & components for use in production
• Organize and issue printed materials to production
• Monitor & interpret charts and gauges
• Log book review, issuance, and archival

Qualifications

• Associate's degree in Science, or equivalent (required)
• Bachelor's degree in Science, or equivalent (preferred)
• 1-4 years' experience in Quality Assurance or Manufacturing, preferably in an FDA regulated environment
• Working knowledge of cGMPs (preferred)
• Knowledge and skill in using micrometers, calipers, and light inspection unit (required)
• Knowledge of Good Documentation Practices
• Ability to thoroughly review large executed production batch records and identify errors that need correction
• Ability to pay close attention to detail and coordinate various activities simultaneously
• Ability to communicate with coworkers, management team members, and other individuals in a courteous and professional manner
• Ability to work with minimal supervision
• Ability to maintain confidentiality
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists

Skills

• Good written and oral communication (essential)
• Technical writing (plus)
• Highly motivated, self-starter with knowledge of contemporary cGMP practices and procedures
• Effective time management