In Process Quality Assurance Auditor (12 Hr Night Shift 7p-7a)

In Process Quality Assurance Auditor

The In Process Quality Assurance Auditor ensures consistent product quality through independent inspection in process testing, verification and auditing of pharmaceutical drugs during manufacturing and packaging within a cGMP-regulated pharmaceutical manufacturing environment. This position provides intermediate-level Quality Assurance support across manufacturing, warehousing and packaging operations. The In Process Quality Assurance Auditor applies critical thinking, analytical reasoning, and sound judgment to evaluate data, identify deviations, and ensure compliance with internal procedures and regulatory requirements (FDA, DEA).

Quality Assurance Operations

1. Promote and ensure compliance with current Good Manufacturing Practices (cGMPs) and all applicable regulatory standards.
2. Independently perform in-process inspections throughout manufacturing and packaging operations to verify conformance to specifications.
3. Conduct verification of production operations and environmental conditions prior to line clearance and batch initiation.
4. 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 as the process is in production; verify data accuracy and documentation integrity. Identify out of trends or non conformances from documented data or auditing on the line from in process testing results, review of label print and application, DSCSA serialization/aggregation, downtime activities, and proactively communicate to put in corrective actions prior to the product being removed from the area. Record inspection results and maintain accurate data in quality systems (SAP, WMS, and other databases).

1. Identify, segregate, and document non-conforming events on the process line, and halt the processing if critical compliance activities are identified. Ie, product spills, equipment set up incorrectly, label print incorrect, mixed components on the line,
2. Immediately escalate non conformance 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.

1. Support Process Issues (PIs) and Corrective and Preventive Actions (CAPAs) by providing detailed, factual information.
2. Collaborate with manufacturing and packaging personnel to resolve quality issues and ensure adherence to quality standards.
3. Participate in continuous improvement activities to enhance product quality and operational efficiency.

1. Conduct packaging room and line clearance inspections prior to production start-up.
2. Verify reconciliation of components after batch completion and ensure proper documentation and return to inventory.
3. Exercise judgment and problem-solving skills to identify potential quality risks in packaging operations.

Continuous Improvement and Compliance

• 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.

Education and Experience

• 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 required.
• 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.

Knowledge, Skills & Abilities

• 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.

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

PAI Pharma is a nicotine-free campus, meaning the use of nicotine productsincluding cigarettes, vaping, chewing tobacco, and any other nicotine-containing substancesis strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.

EEO Employer / Veteran / Disabled