Stability Coordinator

SUMMARY: 

The Stability Coordinator will be responsible for managing and maintaining the R&D stability program. This will include initiating stability studies, coordinating stability pulls, making sure the testing schedule of stability samples is met, analyzing stability data, and evaluating trends, and writing stability reports. The Stability Coordinator will interact with other groups in R&D and other departments (such as QC and production) as required. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

Includes the following, but other duties may be assigned as the company's needs dictate.

• Responsible for overseeing all stability operations.

• Confer with other R&D groups and other departments to identify products to be studied, the test criteria to be used, and the type of stability studies to be performed.

• Document stability samples received and verified that they are labeled appropriately.

• Ensure that pulls of stability samples are done according to schedule, and that testing, and evaluation procedures are carried out in a timely manner.

• Analyze stability study data, evaluate trends over the product shelf life, and compile these data into reports.

• Perform and document data recording and calibration of environmental chambers and other equipment.

• Develop a working knowledge of regulatory requirements of customer countries.

• Operate the stability program according to FDA, cGMP regulations, USP practice, and ICH guidelines.

• Oversee the management and maintenance of the stability lab.

SUPERVISORY RESPONSIBILITIES: 

None.

QUALIFICATIONS: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE: 

Bachelor’s degree (B.A. or B.S.) in a scientific discipline; and 2 or more years related experience and/or training; or equivalent combination of education and experience. Must demonstrate knowledge of common analytical tools and techniques. Must have previous experience with conducting stability studies and knowledge of statistics. Must have previous experience in a GMP environment. 

LANGUAGE SKILLS: 

Ability to read, analyze and interpret common scientific literature, technical journals, and legal documents. Ability to write reports, business correspondence and analytical methods procedures. Ability to effectively present information to company management and staff.

MATHEMATICAL SKILLS: 

Ability to apply mathematical concepts such as exponents, logarithms, quadratic equations, and statistical formulas.

COMPUTER SKILLS: 

To perform this job successfully, an individual should have knowledge of Spreadsheet software and Word Processing software.

REASONING ABILITY: 

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.