<p>Description</p> <p>Job Purpose:</p> <ul> <li>Manage the day-to-day operations of the QC Chemistry laboratory in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA and DEA regulations. </li><li>Implement practical process improvements to reduce sample lead times and improve turn-around times for lab testing. </li><li>Recruit, train, manage, and mentor direct reports. </li><li>Maintain a flexible organization to allow fast changing manufacturing priorities to occur with minimum disruption and avoid back logs. </li><li>Ensure the Quality Control group is fully compliant with all cGMP requirements including adequate maintenance and cleanliness of equipment and laboratories. </li><li>Ensures the quality of laboratory operations and analytical testing meets or exceeds industry standards. </li><li>Performs other duties as assigned or apparent. </li></ul> <p>Essential Duties and Responsibilities:</p> <ul> <li>Plans, organizes, and manages resources on projects to assure technical and regulatory quality, budget and schedule adherence. </li><li>Lead QC Supervisors to ensure sample release plans and schedule adherence are achieved. </li><li>Establish, maintain and report key performance indicators for the department with respect to daily operations. </li><li>Actively participate in internal and external audits and follow up on audit findings. </li><li>Supports the day-to-day process of laboratory investigations including, but not limited to OOT and OOS investigations. </li><li>Monitors and trends Corrective and Preventive Actions from the conclusion of Laboratory investigations to include Analyst trending, Method tracking, and Product tracking. </li><li>Ensure all laboratory equipment is maintained and support troubleshooting. Identify and purchase of new equipment as needed. </li><li>Oversee the Operations of the Quality Control Chemistry Laboratory and assure operations are conducted in accordance with regulatory requirements and expectations. </li><li>Responsible for drafting SOPs related to Analytical Services functions, equipment, documentation, and/or processes. </li><li>Develop and approve methods and results including: product specifications; protocols, SOPs, and reports for analytical method validation and stability studies; IQ/OQ/PQ protocols and reports for equipment; master production records. </li><li>Assists staff in developing solutions to complex technical and regulatory problems and investigation of unexpected results. </li><li>Capable of defining strategic objectives for the QC Chemistry department as well as generating and implementing initiatives that improve the department efficiency and the quality of the results. </li><li>Day to day employee personnel management including, but not limited to time card approvals, performance reviews, and addressing personnel matters. </li></ul> <p>Knowledge & Skills:</p> <ul> <li>Strong knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements. </li><li>Must have strong project management skills and be able to provide technical vision and direction with compliance to standards in order to meet business initiatives. </li><li>Must possess direct experience in analytical method development, transfer and validation. </li><li>Must possess a strong experience base in product QC testing and release procedures and documentation. </li><li>Must be detailed oriented and have excellent organizational skills. </li><li>Must possess effective written and oral communication skills and be able to handle multiple projects within limited time frames. </li><li>Must have skills in HPLC, GC, and mass spectroscopy detection technologies. </li><li>Must have excellent communication and technical writing skills. </li><li>Expected to be a leader in the technology area and to train others for more routine and specific project-oriented applications. </li><li>The ability and willingness to change direction and focus to meet shifting organizational and business demands. </li><li>The ability to create and contribute an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. </li><li>The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. </li><li>The ability to manage a multitude of resources and to be accurate and current with data and information. </li></ul> <p>Education/Experience:</p> <ul> <li>Minimum Bachelor's degree and/or 10 years of experience working in Quality Control Chemistry </li><li>Experience with cGMP documentation systems and with implementation of quality control systems. </li><li>Preferred experience in analytical method development, transfer and validation. </li><li>Must possess a strong experience base in product QC testing and release procedures and documentation. </li><li>Salary Range: Based on experience </li></ul> <p>Working Conditions / Physical Requirements:</p> <ul> <li>Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing. </li></ul>