Analytical Services QC Manager

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