Quality Assurance - Stability Coordinator

Title: Stability Coordinator

Reports to: Manager, Quality Systems/Validations

Department: Quality Assurance

Organizational Relationships: Batching & Filling/Assembly areas, Customer Reps, Customers, Approved Testing Labs and Warehouse/Shipping personnel.

Responsibility Summary: The Stability Coordinator is responsible for managing all aspects of stability sample preparation, submission, and documentation in compliance with approved protocols and cGMP standards. Key duties include coordinating with testing laboratories, maintaining accurate logs, monitoring stability chambers, and preparing detailed reports for quality review. The role ensures timely tracking of test results, supports regulatory requirements, and promptly reports any out-of-specification findings to the Quality team.

Responsibilities:

The Stability Coordinator is responsible for supporting the company's business events through a variety of tasks, including:

• Reviews batch and finished product stability samples using approved stability protocol, current product specifications and sample submission forms
• Prepares stability samples and submission documents.
• Co-ordinates with testing labs as required
• Facilitates maintenance of awareness and compliance with cGMP and safety regulations in production, manufacturing and related areas
• Maintain current logs (with sent dates, result due dates, result receipt dates, etc) for all stability samples to support approved protocols
• Daily / Periodic monitoring and documentation of (a) Walk-in; (b) Reach-in; and (c) Freeze/Thaw chambers and their parameters such as temperature and humidity, PM, calibration, Water supply, etc.
• Must be familiar and current with Englewood SOP 1-050 (Operating, Maintaining and Monitoring of Stability Chambers); SOP 1-033 (Stability Testing for Drug Products) and Englewood Lab Quality Form, EQF 206, 207, 022 and EQF 121
• Prepares stability sample submission documents to cover long term, accelerated, freeze-thaw, intermediate (if applicable), preservative challenge test (PET).
• Maintains stability reports including compatibility, analytical method validation, and PET.
• Assemble on-going, in-progress, and completed reports for review by QC Manager or designee
• Maintain tracking logs and correspondence to support stability sample submission to approved labs and for customer evaluation.
• Immediately notify Quality personnel if out-of-specification (OOS) is observed in stability test results.
• Periodically review stability logs for completeness.
• Ensure that only most current versions of product specifications are used for product testing by the approved labs.
• Ensure on-time submission of samples and receipt of results/customer approvals.
• Maintains awareness and compliance with US FDA, ICH Stability, GMP and safety regulations in performing job duties.
• All other functions and duties as may be assigned by immediate supervisor
  
  

Qualifications:

• Associate’s degree (2-year college degree) required
• Experience in cosmetic, device, food or pharmaceutical inspection process preferred.
• Good math skills
• Ability to read and interpret internal and external sampling plans and effectively report results
• Effective communication skills with internal and external customers
• Ability to lift and carry up to 10-15 pounds.
  
  

This position is Full-Time, Onsite in Totowa, New Jersey, five days per week in the office (9:00AM - 6:00PM)

Compensation & Benefits:

The approximate pay range for this position is $50,000 - $60,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities.

The benefit package includes:

• Medical, Dental, Vision, Life
• PTO
• Special Paid Leave for employees’ personal events
• Company Paid Holidays
• 401(k) employer match
• Year-End Gift
  
  

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