Stability Coordinator I

SUMMARY OF POSITION

The Stability Coordinator I is responsible for all aspects of the stability sample program. The Stability Coordinator initiates and manages stability studies, including protocol development and maintenance, sample handling, and data reporting.

ORGANIZATION STRUCTURE

The Stability Coordinator I reports to a QC Manager or Team Leader.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

1. Master Stability Protocol Management

a. Create and maintain Master Stability Protocols based on the registered requirements and in compliance with all current ICH/FDA regulatory guidance.

b. Work directly with project team to define stability commitments for study design, testing requirements, and material specification references.

c. Calculate the number of samples required per study based on pack types and storage conditions.

d. Review specification changes for products to assess impact to Master Stability Protocols and revise protocols as needed using appropriate change management systems.

2. Study Protocol Management

a. Create, review, and/or approve stability study protocols and summary report tables.

b. Submit sample request forms to be included with the production records for individual stability studies.

c. Assign stability study identification numbers and stability sample quantities to individual study protocols.

d. Ensure stability samples are labeled properly and placed in the correct conditioned chamber(s) for storage.

e. Revise stability study protocols as needed throughout study lifetime.

3. Study Scheduling and Implementation

a. Perform stability study sample pulls according to daily pull schedule.

b. Review and ensure the correct samples are pulled and delivered to the appropriate NPI laboratory when due.

c. Provide stability data to customers when applicable.

d. Dispose of stability samples when study is completed or discontinued.

e. Work with metrology department on chamber monitoring and maintenance.

f. Participate in stability improvement projects.

4. Compliance Activities

a. Complete corrective and preventive actions when assigned.

b. Prepare stability data tables and summary reports as needed for customer Annual Reports or ongoing regulatory and/or stability data review processes.

c. Review stability summary data tables for compliance and possible trends. Ensure any stability issues or potential issues are appropriately communicated to laboratory management.

5. Additional duties as required

QUALIFICATIONS

1. A degree in life sciences, plus 1-3 years of pharmaceutical experience, or equivalent combination of education and experience.

2. Excellent oral and written communication skills.

3. Proficient in computer use (Word, Excel, PowerPoint, internet) with ability to learn new computer applications.

4. Ability to comprehend and follow standard operating procedures and test methods.

5. Strong attention to detail and ability to multitask.

6. Operates with a sense of urgency in a fast-paced environment.

7. Strong organization, communication, and interpersonal skills.

GMP DECISION-MAKING AUTHORITY

1. Authors regulatory documents and reports.

2. Authors and revises stability protocols.

3. Maintains and implements stability sample pull schedule.

4. Reviews and reports stability data.

5. Participate in audits as required.

The anticipated base salary for this position is $62,354.00. This position is eligible for Alvogen’s annual discretionary bonus and comprehensive benefits package, consisting of medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution), dental, vision, flexible spending accounts. Alvogen’s benefits package also includes a retirement savings program, long-term care coverage, paid time off (176 hours per year, prorated to hire date) inclusive of sick time, disability benefits, life insurance, a wellness program, and 13 company recognized paid holidays per year. We anticipate this position will be posted on [Posting Date] and remain open for at least 20 days. To apply, select the apply button and submit your application.

An Equal Opportunity Employer, including disability/vets