The Stability Coordinator will coordinate stability operations activities and ensure quality products and systems. Activities to include protocol development, equipment management, internal and external testing coordination, scheduling, stability data compilation and analysis.
Coordinate stability operation activities and ensure quality products and systems
Determine stability sample requirements, develop stability protocols and oversee execution of stability protocols;
Monitor stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications;
Prepare stability data graphs to estimate expiration dates and verify product shelf life
Evaluate stability trends and prepare reports;
Initiate action reports or deviation reports for any applicable nonconformance
Assist with the filing and archiving of stability studies;
Provide a quality review process for data generated in the stability group
Work closely with team leader regarding work scheduling and assignments;
Coordinate outside contract testing;
Work with internal and external auditors; may be required to act as spokesperson on behalf of company;
Work with accounting on administration of stability storage charges;
May recommend cost improvements and provide advice on routine operational procedures as related to stability testing;
May oversee and train a small group (i.e., 1-3 administrative support / technical staff)
May serve on project teams.
Must be proficient in Microsoft Office and other software using a personal computer;
Requires intermediate to advanced Excel skills;
Knowledge of and ability to work with equipment, supplies, components and technical areas that are utilized in the pharmaceutical industry, i.e., weighing equipment and controlled environmental chambers;
Knowledge of microbiology testing and analysis is a plus;
Knowledge of FDA guidelines on Stability requirements is a plus;
Must have program management skills and scheduling abilities;
Able to develop and implement efficient functional systems;
Quality minded with ability to perform work with detailed accuracy and in accordance with established procedures
Must be able to analyze data and work with a high degree of accuracy;
Organized and able to perform duties in a timely manner;
Must be flexible and able to handle multiple activities;
Able to exercise independent intellectual judgment based on their specialized skills in the field of science;
Good verbal and written communication skills;
Able to effectively communicate with team leader, other departments, and vendors;
Must be available for on-call duty rotation;
Job requires handling of investigational products, active ingredients, and common laboratory chemicals. The individual must be able to handle these items in accordance with normal safety precautions;
Vision suitable for performing detailed inspections;
May be required to move items weighing up to 25 lb.
Bachelors degree in pharmacy, chemistry or related scientific field plus one year relevant experience; or AS degree plus 10 years relevant experience or 3 years directly related pharmaceutical job experience; or HS diploma plus 15 years relevant experience or 5 years directly related pharmaceutical job experience.
Experience in GMP quality control and/or pharmaceutical manufacturing facility;
Pharmaceutical stability operations experience.
Please send resume and salary requirements to HR@horizonph.com. No phone calls please.
Horizon Pharmaceuticals, Inc. is an Equal Opportunity Employer dedicated to providing equal opportunity to all employees and applicants regardless of race, color, age, gender, sexual orientation, national origin, marital or veteran status, disability or any other basis protected by federal, state or local law. The company is committed to providing equal employment opportunity with respect to recruitment, selection and all terms and conditions of employment.