QC Chemistry Operations Supervisor

Description

Job Purpose:

• Assist in overseeing 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. 

• Assist in the implementation of practical process improvements to reduce lead times and improve turn- around times for lab testing. 

• Help 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.

• Recruit, train, manage, and mentor direct reports.

• Performs other duties as assigned or apparent. 

Essential Duties and Responsibilities:

• Plans, organizes, and manages resources for sample testing to maintain laboratory workflow and schedule adherence. 

• Verify notebooks, raw data, and COA’s before final QC approval. 

• Verify data entry in the Laboratory Information Management Systems conform to final product specifications. 

• Provide management approval for final product release. 

• Assist in establishing, maintaining, and reporting key performance indicators for the department with respect to daily operations.

• Assist in overseeing the QC Chemistry lab operations and assure operations are conducted in accordance with regulatory requirements and expectations. 

• Responsible for drafting, editing, and approving SOPs related to Analytical Services functions, equipment, documentation, and/or processes. 

• Assist with the day-to-day process of laboratory investigations including, but not limited to OOT and OOS investigations.

• 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. 

• Direct, perform and resolve out-of-specification investigations and implement corrective and preventative actions 

· Day to day employee personnel management including, but not limited to time card approvals, performance reviews, and addressing personnel matters. 

· Capable of defining strategic objectives for the Analytical Services department as well as generating and implementing initiatives that improve the department efficiency and the quality of the results and processes. 

Knowledge & Skills:

• Knowledge of FDA manufacturing/regulatory      quality systems regulations, qualification, facilities and investigation      requirements. 
• 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 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 5 years of      experience working in Quality Control Chemistry and/or Research &      Development. 
• 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. 

The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be r