Job Title: Quality Sample Coordinator

Job Description

The Quality Sample Coordinator will oversee and confirm compliance in compounding processes, including room clearance, verification of material status, weighing, mixing, charging of chemicals, in-process quality attributes, and autoclave procedures. This role involves coordinating samples for clean rooms, verifying proper gowning by all personnel, and monitoring environmental activities. You will generate deviations, issue CAPAs, and manage change controls in response to observations. Additionally, you will collaborate with Quality Assurance Management on quality issue tracking, trending activities, batch record review, batch release, visual inspection, and other tasks assigned by management.

Responsibilities

• Oversight and confirmation of compliance in compounding processes.
• Coordination of samples for clean rooms and verification of proper gowning.
• Verification of environmental monitoring activities, including plating and personnel monitoring.
• Generation of deviations and issuance of CAPAs and Change Controls.
• Follow-up on quality issue tracking and trending activities.
• Batch record review and batch release.
• Visual inspection and participation in regulatory audits.
• Assist process owners with root cause analysis.
• Prepare and monitor Quality Metrics and KPIs.
• Perform duties in accordance with established company procedures and policies.

Essential Skills

• 3+ years of experience in aseptic drug product manufacturing.
• 2 years of aseptic experience within a GMP lab.
• Fundamental knowledge of safety, quality systems, and quality assurance concepts.
• Strong familiarity with manufacturing process and operations, automation, and equipment validation.
• Familiarity with FDA inspections and audits.
• Investigation writing skills.
• Ability to complete tasks with little direction or supervisory follow-up.
• Strong written, verbal, and presentation communication skills.
• Strong computer skills in database management and documentation preparation.
• Ability to think creatively and confront new issues.

Additional Skills & Qualifications

• Knowledge of current Good Manufacturing Practices (cGMP) guidelines.
• Close visual acuity for defect inspection.
• Attention to detail.
• Proper use of personal protective equipment and aseptic procedures.
• Accurate completion of production documentation and logbooks.

Work Environment

This position is part-time, working 30 hours per week on the first shift from 8am to 4:30pm. You will work in 503B clean rooms alongside the Quality Team, ensuring compliance with company safety policies, cGMP, and SOPs. The role offers exposure to different departments and a great opportunity to learn about GMP practices. You will be working hands-on with manufacturing production equipment and technologies in ISO7, ISO8, and other classified areas.