Quality Control Raw Materials Manager Job in Huntsville, Alabama US
Quality Control Raw Materials Manager
Manage the Quality Control Raw Material Program across multiple plants in the Qualitest QC organization. Responsible for planning, organizing, and leading continuous improvement efforts to ensure consistency in execution of raw material release testing, and availability of released materials to support production schedules. 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 directed at providing commercial QC support to the operation in order to meet production requirements, support process excellence, and to become a key focal point in QA/QC processes by working with plant personnel to ensure the business quality targets are met. Key Responsiblities: Ensure alignment with business requirements as well as regulatory and compendial requirements. Maintain open communication with Purchasing, Regulatory Affairs, and R D regarding vendor specifications and test methods. Control and maintain harmonization of RM practices among all facilities. Ensure consistency for personnel training and development. Oversee and approve change controls for procedures, methodologies 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. Assist in governmental inspections as needed. Ensure periodic audits are performed Ensure reviews of compendial documents are performed and oversee revision of current procedures as needed 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: 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. Previous Supervisory experience in a plant environment 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.