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Stability Supervisor, Quality Laboratory Services

Company: Renaissance LLC
Location: Lakewood
Posted on: September 3, 2020

Job Description:

Job Description: Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Stability Supervisor, Quality Laboratory Services oversees and coordinates the daily activities of the Quality Laboratory Services Stability Group to ensure that technical data and documentation generated by Stability function is accurate and meets all established protocol and Client timelines. The Stability Supervisor interacts with other functional departments to ensure Stability services are provided timely, efficiently and in compliance with all Renaissance and cGMP standards. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Responsibilities Technical --- Perform/oversee Stability DEA inventory. --- Ensure the accurate and timely input of QC data into the stability information systems: e.g.: ScienTek or LIMS system. --- Act as primary point of contact for Stability team members when problems or issues arise and facilitate resolution of issues. --- Identify, conduct and lead opportunities to continuously improve quality, cost and efficiency of processes in accordance with the strategic direction of the department to fulfill company and department goals. --- Actively participate in cross functional teams for problem solving and continuous improvement. --- Manage and update stability program SOPs as required. --- Review and implementation of regulatory requirements for stability program. --- Generation, review, approval, and execution of stability protocols in LIMS. --- Proficient in ScienTek, LIMS or equivalent system to create and initiate stability studies. --- Prepare documentation of trend analysis reports, and stability summary reports for regulatory submissions. --- Proficient in trend analysis using statistical software (LIMS). --- Ensuring that all chemical and microbiology tests associated with drug product stability studies is completed per approved SOPs. --- Labeling and storage of stability samples. --- Monitoring the periodic maintenance and calibration of company stability chambers. People Management --- Direct the work activities of the Stability group to ensure that stability studies are initiated, pulled, and reported in a timely and compliant manner. --- Monitor and coach performance of team members. Conduct annual performance reviews. --- Monitor employee performance and provide appropriate and timely recognition of their contributions. --- Ensure adequate training and development opportunities for QLS employees. --- Assist employees in setting career goals and managing career expectations. --- Provide guidance as requested regarding hiring, training, promotions, and disciplinary issues for technical personnel. --- May interview prospective department personnel. --- Understand and comply with all Renaissance safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations. Qualifications Bachelor's degree in a Natural Science with 5 - 8 years of experience in stability science or analytical chemistry within the pharmaceutical industry. Prior stability data statistical trend analysis experience is preferred. Additional education may be substituted for experience on a year per year basis. PI123096191

Keywords: Renaissance LLC, Lakewood , Stability Supervisor, Quality Laboratory Services, Other , Lakewood, New Jersey

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