Stability Coordinator II at Amneal Pharmaceuticals LLC (J0P) in Piscataway, New Jersey

Job Description:

Description:

The Stability Coordinator II is responsbile for implementing, leading and managing the stability program for all products, will handle investigations, write protocols and Standard Operating Procedures (SOPs).

Essential Functions:

• Manage the stability program for all commercial products including validation batches and annual check lots; which includes initiating stability studies in the system and entering the stability specifications for products to be placed on stability for studies of new products undergoing validations prior to approval.

• Handle the distribution and pull of stability samples to and from designated stability storage. Maintain daily temperature/humidity records as identified in logbooks for each stability room/chamber. Assemble weekly charts on chart recorders and remove weekly completed chart. Provide stability data summaries for Annual Product Reviews and Annual reports as per schedules. Provide monthly pull schedules to laboratory manager/supervisor so that work load can be assessed.

• Prepare, review and approve stability protocols for all products including products from customers if required. Identify reduction of stability intervals for annual check lots of products where sufficient data have been accrued.

• Perform investigations related to stability storage conditions being out-of limits, conduct impact assessment, and prepare stability data summary reports on an on-going basis, review stability data to identify any adverse trends, if observed, escalate such to laboratory management.

• Identify extra samples in the storage area that would need to be discarded.

Additional Responsibilities:

• Perform regression analysis of stability data. Prepare justifications, when required for extension of expiration dating. Other duties as assigned.

Education:

• Associate Degree Chemistry or related science discipline:  Required

• Bachelors Degree (BA/BS) Chemistry or related science discipline:  Preferred

Experience:

• 5 years or more experience managing a stability program is required.

• 3 years or more experience with a BA/BS managing a stability program is preferred.

Skills:

• Must be detail-oriented, meticulous, precise and consistent in stability sample information in the stability database. Must be flexible to adapt to changes in assignments. Must be well versed with Microsoft office programs. Must have great communication skills, both verbally and in writing. Must be able to identify trends in analytical data. Must be able to use good judgment and troubleshoot problems. Quick learner and able to obtain new knowledge needed to complete tasks. Must be able to work in a team environment. - Advanced

Specialized Knowledge:

• Must possess understanding of stability data with respect to specification. Must be familiar with current stability guidance from the Agency. Proficient in MS office applications, software programs related to LIMS. Must understand and apply cGMP requirements.