Job Description

Job Purpose:

• 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.
• Implement practical process improvements to reduce sample lead times and improve turn-around times for lab testing.
• Recruit, train, manage, and mentor direct reports.
• Maintain a flexible organization to allow fast changing manufacturing priorities to occur with minimum disruption and avoid back logs.
• Ensure the Quality Control group is fully compliant with all cGMP requirements including adequate maintenance and cleanliness of equipment and laboratories.

· Ensures the quality of laboratory operations and analytical testing meets or exceeds industry standards.

• Performs other duties as assigned or apparent.

Essential Duties and Responsibilities:

• Plans, organizes, and manages resources on projects to assure technical and regulatory quality, budget and schedule adherence.
• Lead QC Supervisors to ensure sample release plans and schedule adherence are achieved.
• Establish, maintain and report key performance indicators for the department with respect to daily operations.
• Actively participate in internal and external audits and follow up on audit findings.
• Supports the day-to-day process of laboratory investigations including, but not limited to OOT and OOS investigations.
• Monitors and trends Corrective and Preventive Actions from the conclusion of Laboratory investigations to include Analyst trending, Method tracking, and Product tracking.
• Ensure all laboratory equipment is maintained and support troubleshooting. Identify and purchase of new equipment as needed.
• Oversee the Operations of the Quality Control Chemistry Laboratory and assure operations are conducted in accordance with regulatory requirements and expectations.
• Responsible for drafting SOPs related to Analytical Services functions, equipment, documentation, and/or processes.
• 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.
• Assists staff in developing solutions to complex technical and regulatory problems and investigation of unexpected results.
• 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.
• Day to day employee personnel management including, but not limited to time card approvals, performance reviews, and addressing personnel matters.

Knowledge & Skills:

• Strong knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements.
• 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.
• Must possess direct experience in analytical method development, transfer and validation.
• Must possess a strong experience base in product QC testing and release procedures and documentation.
• Must be detailed oriented and have excellent organizational skills.
• Must possess effective written and oral communication skills and be able to handle multiple projects within limited time frames.
• Must have skills in HPLC, GC, and mass spectroscopy detection technologies.
• Must have excellent communication and technical writing skills.
• Expected to be a leader in the technology area and to train others for more routine and specific project-oriented applications.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to create and contribute an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to manage a multitude of resources and to be accurate and current with data and information.

Education/Experience:

• Minimum Bachelor’s degree and/or 10 years of experience working in Quality Control Chemistry
• Experience with cGMP documentation systems and with implementation of quality control systems.
• Preferred experience in analytical method development, transfer and validation.
• Must possess a strong experience base in product QC testing and release procedures and documentation.
• Salary Range: Based on experience

Working Conditions / Physical Requirements:

• Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing.