QC Quality Control Sr. Lab Manager

My client is a pioneer in the pharmaceutical and nutritional medicine field and is slated to triple in revenues over the next few years.  We have partnered to fill a critical role in the success of this growth!!


The Quality Control Analytical Laboratory Manager’s primary purpose is to ensure my client's products are safe and unadulterated, in specification, and are of high quality. To accomplish these goals requires the smooth seamless functional operations in the analytical laboratory in support of manufacturing. A key responsibility is to take charge of all investigations related to out of specification raw materials and products, and give analytical assignments both internally and externally to determine the cause in an expedited manner. Additionally, the jobholder is expected to contribute to the development and execution of methods and techniques, acquisition of equipment, budgeting, and expansion needs of the analytical laboratory. Also provide timely and proactive interaction with peers in QA/QC, Operations, and R&D departments.


This position requires extensive knowledge of HPLC, GC, FT-NIR, TLC, UV -VIS, Spectroscopy and other general analytical instrumentation. Requires understanding and implementation of GMPs, GLPs and other applicable regulations. Must have excellent technical writing skills and experience at writing method and process validation protocols and reports. Good instrumentation and process troubleshooting skills are required.


Knowledge and conformance to Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP) as applicable to the position are required!


Essential Duties and Responsibilities:


· Manage QC Analytical Chemists to ensure efficiency, timeliness, and accuracy of testing.  Supervise, train, and develop direct reporting personnel to continually upgrade their skills.


· Have competence in regulatory issues, including method development and validation using current guidelines.


· Responsible for all analytical instrumentation, analytical method development, sample preparation techniques, data and analytical information management.


· Provide the scheduling and priorities of samples for analysis.


· Be able to offer direction for analytical separation techniques, including but not limited to HPLC, AA, ICP, and GC and other evolving technologies.


· Have a firm grasp of pertinent detection techniques, including but not limited to UV and Fluorescence.


· Investigate and further develop new and existing methods and procedures for analysis.  Hands on experience using dissolution apparatus.


· Responsible for leading, performing, documenting, and verbally reporting on laboratory investigations to management.


· Identify analytical lab needs as company vision and company itself evolves, including assisting in budget proposals for personnel and equipment, planning and/or securing adequate facilities for lab operations, and recruiting/hiring analytical lab personnel.


· Generate appropriate paperwork for results of analysis (Certificate of Analysis, analytical reports etc.) and provide interpretation of those results.


· Responsible for all quality assurance of analysis data and maintanance of calibration records for equipment.


· Possess a working knowledge of analytical software packages, laboratory data management, and MS Office.


 


Qualifications and Guidelines:


· Ph.D. in Chemistry preferred with experience managing technical professionals


· Minimum five years of laboratory supervisory/management experience


· Experience with HPLC, UV-VIS, ICP, FT-NIR, analytical software and reporting of data


· Knowledge of regulatory requirements, database management, understanding of the manufacturing flow process and inventory control in MRP


· Strong leadership skills and highly ethical


· Strong interpersonal, management, and communication skills are necessary.


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