Quality Control Stability Manager Job in Huntsville, Alabama US
Quality Control Stability Manager
Manage the Quality Control Commercial Stability Program across the Qualitest QC organization. Responsible for planning, organizing, and leading continuous improvement efforts to ensure consistency in execution of the corporate stability program per approved procedures and product application requirements. The incumbent will be responsible for the development and training of departmental personnel to ensure consistency in execution across the Quality Control organization. The principle activities are to ensure consistency in program design and execution to meet our compliance requirements. Additional responsibilities include the support of process excellence activities pertaining to the laboratory operation, and working with plant personnel to ensure the business quality targets are met. Key Responsibilities: Ensure stability program requirements are aligned across the quality control department to ensure compliance with company procedures and product applications. Maintain open communication with Quality Control and Quality Assurance leadership to ensure escalation and resolution of issues. Control and maintain harmonization of stability program practices among all facilities. Ensure consistency for personnel training and development. Oversee and approve change controls for procedures, methodologies, and stability protocols and specifications as needed. Review and approve OOS/OOT/NOE investigations for completion and compliance to company and regulatory standards. Write Review trends analysis reports for OOS/OOT/NOE investigations. Ensure stability reports are maintained justifying product shelf-life; make recommendations to revise shelf-life requirements based on data trends. Assist in governmental inspections as needed. Ensure periodic audits and inventory checks are performed. Evaluate new technologies and engage in continuous improvement activities to ensure compliance improvement and business efficiency. Oversee and ensure compliance with all procedures related to DEA regulations. Ensure safe work practices exist in all labs in compliance with existing requirements. Requirements : Skills: (Proficiency in manual, verbal or mental manipulation of data or things e.g. specific software skill, data manipulation skills such as modeling) Highly developed interpersonal and organizational skills and demonstrated ability to work with a demanding client base and all levels of management and staff. Proven skills in all phases of directing a laboratory, with demonstrated hands-on analytical testing experience. Education/experience: (The minimal acceptable level of education, work experience, and certifications necessary for employment, e.g. advanced degree on chemistry, previous work experience on drug development) Bachelor?s degree in Chemistry Advanced degree preferred Minimum of 7-10 years of lab supervision and analytical methods development in a plant environment with demonstrated skills to provide leadership in quality and regulatory compliance. Minimum of 5 years managing a stability program Abilities : ( Abilities as evidenced through activities or behaviors that are similar to those required on the job, including Endo-wide competencies, mission critical segment competencies, and functional/job specific competencies, e.g. dealing with ambiguity, action oriented, self-development, and decision quality) Demonstrates the ability to lead, direct, and motivate others Able to articulate technical objectives and strategies effectively to all audiences and have the ability to develop and maintain close relationships with leadership teams and the work force. Ability to trouble shoot day to day challenges in the laboratory, such as those encountered with methods. Knowledge : (Proficiency in a body of information that can be applied directly to accomplish a task, e.g. knowledge of pain therapy, knowledge of particular drugs) Strong knowledge and understanding of GXP regulations. Well versed with the expectations of respective regulatory bodies such as FDA, DEA, etc. that oversees all aspects of drug product manufacturing, handling, storage, and distribution.