Apply on Employer Site

PAI Pharma · 2 weeks ago

In Process Quality Assurance Auditor (Night Shift)

Greenville, SC, US

Full-time

Onsite

Entry, Mid Level

2+ years exp

PAI Pharma is a pharmaceutical manufacturing company focused on ensuring product quality. The In Process Quality Assurance Auditor is responsible for independent inspections and compliance verification during the manufacturing and packaging processes in a cGMP-regulated environment.

B2BBiotechnologyHealth CareManufacturingMedicalPharmaceuticalWholesale

H1B Sponsor Likely

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 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)

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

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

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

Qualification

CGMP complianceQuality Assurance experienceFDA/DEA regulationsSAPERP/WMS systemsMathematical aptitudeCritical thinkingAttention to detailCommunication skillsInterpersonal skills

Required

High school diploma or GED required

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

Strong mathematical aptitude and ability to perform precise calculations and data entry

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

Preferred

Associate degree in a scientific or technical discipline

Proficiency with Microsoft Office (Word, Excel, Outlook) and experience with SAP or equivalent ERP/WMS systems

Company

PAI Pharma

PAI Pharma develops, manufactures and distributes liquid pharmaceuticals to create healthier lives.

Founded in 1968

Greenville, South Carolina, USA

501-1000 employees

http://paipharma.com

H1B Sponsorship

PAI Pharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (2)

2022 (1)