Quality Associate

Planet Pharma; Easton (Northampton County); On-site; USD 52,000 - 68,000; Full time

Job summary

Planet Pharma is seeking a 2nd Shift Quality Associate II in Easton, PA (Tue-Sat, 4pm–Midnight). You will perform inspections, sampling, and testing of incoming materials to ensure GMP compliance and appropriate disposition per client specs.

You'll maintain quality records in QT9, investigate discrepancies, and collaborate with Operations, Inventory, and other teams to resolve issues and drive process improvements while upholding strict regulatory standards.

Qualifications

• 2+ years of Quality Control, Quality Assurance, or related experience in a GMP-regulated environment.
• Pharma or highly regulated experience
• Sampling experience
• Forklift certification or experience is a plus.
• Exposure to multiple temperature-controlled zones including frozen, refrigerated, controlled room temperature, and ambient conditions.

Responsibilities

• Perform inspections, sampling, and testing of incoming raw materials and components in accordance with GMP requirements.
• Evaluate and disposition materials based on client specifications, regulatory standards, and quality requirements.
• Conduct physical inspections of incoming and outgoing materials for damage, discrepancies, or quality concerns.
• Identify and report inconsistencies between shipping documentation, inventory records, and physical product.
• Accept or reject materials based on quality standards, regulatory requirements, and client specifications.
• Operate within GMP-compliant cleanroom environments while adhering to gowning, traffic flow, cleaning, and contamination-control procedures.
• Verify environmental monitoring and cleaning activities are completed prior to performing GMP-related work.
• Support maintenance of quality and compliance standards in controlled warehouse environments.
• Initiate, maintain, and manage quality records within QT9 or similar quality management systems.
• Ensure accurate, complete, and timely documentation of deviations, discrepancies, investigations, and quality events.
• Maintain organized and readily retrievable quality records in compliance with regulatory and company requirements.
• Ensure proper documentation related to client communications regarding discrepancies, damages, and quality issues.
• Partner with Operations, Inventory, and other departments to investigate and resolve material or process deviations.
• Ensure proper client communication regarding quality issues, discrepancies, damages, and product disposition in accordance with SOPs and Quality Agreements.
• Support case management activities by tracking quality issues, identifying trends, and communicating updates to internal and external stakeholders.
• Collaborate with cross-functional teams to ensure non-conforming materials are properly segregated, identified, and controlled.
• Proactively identify quality risks and recommend corrective or preventive actions.
• Support process improvement initiatives that enhance quality, compliance, efficiency, and customer satisfaction.
• Maintain a clean, organized, and inspection-ready work environment.

Skills

Quality control

GMP compliance

Inspections

Education

High School Diploma or GED

Tools

QT9

Job description

2nd Shift Quality Associate II needed in Easton, PA!

Shift: Tues-Sat (4pm-Midnight)

Key Responsibilities:

Quality Inspection & Compliance

• Perform inspections, sampling, and testing of incoming raw materials and components in accordance with GMP requirements.
• Evaluate and disposition materials based on client specifications, regulatory standards, and quality requirements.
• Conduct physical inspections of incoming and outgoing materials for damage, discrepancies, or quality concerns.
• Identify and report inconsistencies between shipping documentation, inventory records, and physical product.
• Accept or reject materials based on quality standards, regulatory requirements, and client specifications.

GMP & Cleanroom Operations

• Operate within GMP-compliant cleanroom environments while adhering to gowning, traffic flow, cleaning, and contamination-control procedures.
• Verify environmental monitoring and cleaning activities are completed prior to performing GMP-related work.
• Support maintenance of quality and compliance standards in controlled warehouse environments.

Quality Systems & Documentation

• Initiate, maintain, and manage quality records within QT9 or similar quality management systems.
• Ensure accurate, complete, and timely documentation of deviations, discrepancies, investigations, and quality events.
• Maintain organized and readily retrievable quality records in compliance with regulatory and company requirements.
• Ensure proper documentation related to client communications regarding discrepancies, damages, and quality issues.

Client & Cross-Functional Collaboration

• Partner with Operations, Inventory, and other departments to investigate and resolve material or process deviations.
• Ensure proper client communication regarding quality issues, discrepancies, damages, and product disposition in accordance with SOPs and Quality Agreements.
• Support case management activities by tracking quality issues, identifying trends, and communicating updates to internal and external stakeholders.
• Collaborate with cross-functional teams to ensure non-conforming materials are properly segregated, identified, and controlled.
• Proactively identify quality risks and recommend corrective or preventive actions.
• Support process improvement initiatives that enhance quality, compliance, efficiency, and customer satisfaction.
• Maintain a clean, organized, and inspection-ready work environment.

Required Qualifications

Education

• High School Diploma or GED required.

Experience

• 2+ years of Quality Control, Quality Assurance, or related experience in a GMP-regulated environment.
• Pharma or highly regulated experience
• Sampling experience
• Forklift certification or experience is a plus.
• Warehouse, office, and GMP cleanroom environments.
• Exposure to multiple temperature-controlled zones including frozen, refrigerated, controlled room temperature, and ambient conditions.
• Fast-paced environment requiring adherence to strict quality and regulatory standards.

Physical Requirements

• Ability to stand, walk, bend, stoop, and perform repetitive movements throughout the workday.
• Ability to lift and move up to 50 pounds.
• Ability to work on concrete flooring in warehouse environments subject to varying temperatures.

Success Metrics

Performance will be measured based on:

• Quality and accuracy of work
• Productivity and timeliness
• Compliance with GMP, SOPs, and quality standards