Senior Compliance Scientist Job in Suffern, New York US
Senior Compliance Scientist
Every day, Kelly Scientific Resources helps scientific professionals with their careers. Kelly is currently staffing for a Senior Compliance Specialist . This position is taking place at a well-known biotech company in Suffern, NY. By working with Kelly in this role, you would be eligible for: - A competitive hourly pay rate with weekly checks - Access to newly expanded Medical Plan options - Online continuing education via the Kelly Learning Center - Several employee discounts - And more! This is a 6 month temporary position at 40 hours per week. JOB DESCRIPTION Responsible for the preparation of the Annual Stability Reports according to the established schedule. Responsible for the preparation of the Annual Product Review Report accor ding to the established schedule. Responsible for the compilation and data interpretation of analytical, manufacturing and regulatory data. Responsible to draw conclusions from real-time data and statistical reports. if available Responsible to ensure that established testing control procedures are followed. Responsible for providing Annual Stability Reports to Drug Regulatory Affairs for timely submission to the Federal Drug Administration. Responsible for providing stability data and reports for product related evaluations, e.g., compliance investigations, divestitures, product transfers, validation, etc. Responsible for managing data and instructing others in the Annual Stability Report writing function. Responsible for serving on various project teams to fulfill activities as assigned. Responsible for writing and updating applicable SOP s Responsible for maintaining ASR/APR schedule. Responsible for the Annual Stability Reports and Annual Product Review Report record keeping. Responsible for the scheduling meetings with the APR Team to determine and assign follow-up action items. Experience: Minimum 5 years in the pharmaceutical industry with an emphasis on Quality Assurance. Demonstrated cGMP knowledge. Applicable PC software knowledge and prior experience with Dragon, ETDI, SAP, MES, LIMS Laboratory Information Management ERP systems. Possess the ability to manage multiple tasks and work independently in ambiguous situations. Excellent technical writing skills, file organization, and the ability to manage data is required. Strong analytical background. Knowledge of stability regulation and its application to the industry. Knowledge of cGMPs. ICH Guidelines Excellent organizational and communication skills. Excellent interpersonal skills including use of tact, diplomacy, discretion and judgement. Interpretation/Analytical data Education: A Bachelor of Science degree in a scientific discipline For immediate consideration, click the "Apply Now! button, or refer a friend by clicking the "E-mail this job" link provided. Kelly Services, Inc. is an Equal Opportunity Employer. Kelly Services connects professionals with opportunities to advance. As the local offices of Kelly Services do not represent the above position, please apply on-line for immediate consideration. For questions regarding this position, please email or phone 4117@kellyservices.com or 732-246-1396.