In Process Quality Assurance Auditor - 12 hour Day Shift (7a-7p)

Ensures consistent product quality through independent inspection, in-process testing, verification, and auditing of pharmaceutical drugs during manufacturing and packaging within a cGMP-regulated environment. Provides intermediate-level Quality Assurance support across manufacturing, warehousing, and packaging operations.

Responsibilities

• Promote and ensure compliance with current Good Manufacturing Practices (cGMPs) and all applicable regulatory standards.
• Independently perform in-process inspections throughout manufacturing and packaging operations to verify conformance to specifications.
• Conduct verification of production operations and environmental conditions prior to line clearance and batch initiation.
• Perform in-process testing (pH, specific gravity, etc.) and assay calculations for compounding operations.
• Review batch records, logbooks, and associated documentation for completeness and compliance during production; verify data accuracy and documentation integrity.
• Identify out-of-trend or non-conformances from documented data, in-process testing results, label print/application, DSCSA serialization/aggregation, downtime activities, and proactively communicate to implement corrective actions.
• Record inspection results and maintain accurate data in quality systems (SAP, WMS, and other databases).
• Identify, segregate, and document non-conforming events on the process line; halt processing if critical compliance activities are identified (e.g., product spills, incorrect equipment setup, incorrect label print, mixed components).
• Immediately escalate non-conformances or observations to management for direction.
• Initiate non-conformances in TrackWise system and assist in investigations.
• Apply critical thinking to evaluate quality data, assess deviations, and determine appropriate actions or escalation.
• Support Process Issues (PIs) and Corrective and Preventive Actions (CAPAs) by providing detailed, factual information.
• Collaborate with manufacturing and packaging personnel to resolve quality issues and ensure adherence to quality standards.
• Participate in continuous improvement activities to enhance product quality and operational efficiency.
• Conduct packaging room and line clearance inspections prior to production start-up.
• Verify reconciliation of components after batch completion and ensure proper documentation and return to inventory.
• Exercise judgment and problem-solving skills to identify potential quality risks in packaging operations.
• Support the development and revision of SOPs, Work Instructions (WIs), and related quality documents.
• Assist with internal audits and data collection for quality reporting.
• Provide on-the-job training to QA Inspector I or new team members as assigned.
• Maintain up-to-date knowledge of cGMPs, regulatory requirements, and company quality policies.

Requirements

• High school diploma or GED required; associate degree in a scientific or technical discipline preferred.
• Minimum 2 years of Quality Assurance or Quality Control experience in a pharmaceutical or regulated manufacturing environment.
• Demonstrated understanding of FDA/DEA regulations, cGMP compliance, and documentation practices.
• Proficiency with Microsoft Office (Word, Excel, Outlook) and experience with SAP or equivalent ERP/WMS systems preferred.
• Strong mathematical aptitude and ability to perform precise calculations and data entry.

Skills

• Advanced critical thinking and analytical reasoning skills – able to evaluate data, identify trends, and make quality-based decisions.
• Strong attention to detail, accuracy, and documentation discipline.
• Excellent communication skills, both verbal and written.
• Ability to manage multiple priorities and work effectively under minimal supervision.
• Strong interpersonal skills with the ability to work collaboratively across departments.
• Self-motivated, dependable, and demonstrates high ethical and professional standards.

Physical Requirements & Working Conditions

• Regularly required to stand, walk, sit, talk, and hear.
• Occasionally required to climb, balance, stoop, kneel, crouch, or crawl.
• Must be able to lift up to 50 lbs.
• Visual requirements include close, distance, color, and depth perception.
• Work is performed in both office and manufacturing environments with exposure to moving mechanical parts and occasional contact with chemicals.
• Must comply with gowning and cleanroom entry requirements.
• Moderate noise level typical of manufacturing environments.

PAI Pharma is a nicotine-free campus; the use of nicotine products is strictly prohibited on company property.