QA Auditor

Job Description

We are seeking a motivated and detail-oriented QA Auditor to join our team. In this role, you will perform essential line audits of pharmaceutical filling and packaging operations and ensure compliance with SOPs. You will also conduct line clearances, in-process, and end-item inspections, and review specifications for acceptance of packaging components, raw materials, and finished products. Additionally, you will be responsible for generating, reviewing, and issuing batch production records, releasing materials for production, and organizing printed materials for production. The position requires a strong knowledge of contemporary cGMP practices and procedures, as well as excellent written and oral communication skills.

Responsibilities

• Perform in-house line audits of pharmaceutical filling and packaging operations.
• Review manufacturing activities and documentation for compliance with SOPs.
• Conduct line clearances, in-process, and end-item inspections.
• Apply specifications for acceptance of incoming packaging components, raw materials, and finished products.
• Generate, review, and issue batch production records.
• Release materials and components for use in production.
• Organize and issue printed materials to production.
• Monitor and interpret charts and gauges.
• Review, issue, and archive log books.

Essential Skills

• Quality assurance and auditing skills.
• Experience with internal audits, compliance, and inspections.
• Proficiency in using micrometers, calipers, and light inspection units.
• Knowledge of Good Documentation Practices.
• Ability to review large executed production batch records thoroughly.
• Strong attention to detail and ability to coordinate activities simultaneously.
• Effective time management skills.
• Excellent written and oral communication skills.

Additional Skills & Qualifications

• Associates degree in Science or equivalent is required.
• Bachelors degree in Science or equivalent is preferred.
• 1-4 years' experience in Quality Assurance or Manufacturing, preferably in an FDA regulated environment.
• Working knowledge of cGMPs is preferred.
• Technical writing skills are a plus.

Work Environment

The work environment includes clean rooms, manufacturing facilities, and labs. The typical first shift schedule consists of four 10-hour days, with standard work hours from 6:00 AM to 4:30 PM. Flexibility in availability for various days of the week and a five-day schedule may be required. Overtime rates apply for hours worked over 40 per week. Alternative work hours or schedules may be required at the discretion of management.