Quality Assurance - Stability Coordinator
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.
- 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.
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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