Quality Manager Job at Arkema Inc in Geneseo, New York

Job Description:

Reports directly to the Plant Manager and dotted line to Regional Director of Manufacturing.Direct reports include 1 Lead Lab technician and 4 Lab Technicians in Geneseo and dotted line reports of QC leads for4 Business unitsites in Texas,Virginia,Mexico and Brazil.

Geneseo: Responsible for direct customer liaison as related to the daily operation of the Quality Control Lab. Ensure efficient management of all Quality Systems and AIMS program. Responsible for developing and maintaining robustness in the quality system to comply with ISO 9001 and AIMS guidelines. Responsible for the maintenance of the analytical control of the lab methods and corrections, specialized product testing and upkeep of analytical instrumentation.

BU: Leads the standardization efforts across the five America's BU sites on quality related procedures, processes and forms related to cGMP, ICH Q7, FDA guidelines, ISO 9000, AIMS elements and BU specific standards. Examples of the later include customer complaint handling, specifications, analytical techniques, etc. Essentially, this role is the 'go-to' person for quality related questions or issues in the BU in the Americas region.

Geneseo (65%)

• Responsible for management of Food Safety Management System (FSMS), and serves as Preventive Controls Qualified Individual (PCQI); manage and organize the work of the Food Safety Team (FST); ensure relevant training and competencies for the FST; report to top management on the effectiveness and suitability of the FSMS.


• Maintain compliance and serve as representative for cGMP, ICH Q7, FDA, Kosher and Halal requirements which includes the Drug Master File, cGMP procedures and routine auditing related to the pharmaceutical grade Benzoyl Peroxide (ICH Q7).


• Manage AIMS program; provide leadership and direction to element champions and serve as primary contact for audits.


• Maintain ISO 9001 quality system certification and serve as contact for all quality related audits; monitor the efficiency of the quality system by performing internal audits at regular intervals.


• Lead the coordination and or investigation of all customer complaints.


• Install and maintain data in SAP and LIMS.


• Manage non-conforming product system.


• Ensure all laboratory facilities, instruments and inventory are maintained in an efficient and safe manner.


• Directs supervision of lab techs; motivates team for high productivity.


• Maintain a system for monitoring regulatory requirements and trends, including QA related issues within the industry.


• Coordinate special analytical requests of Operations, Technical, R&D, sales and Marketing.


• Develop analytical and standard operating methodology as needed.


• Ensures employees work safely by conducting safety inspections and adhere to safety regulations and procedures.


• Train technicians in current laboratory procedures and instrumentation as needed.

BU Regional (35%)

• Quality processes
  
  
  • Responsibility and authority for reporting to top management, Plant LT and / or BU LT, whichever is appropriate, on the performance of the quality system and any need for improvement.
  
  
  • Leads effort to collect ideas on how to continuously improve quality of products and customer's perception of quality, prioritizes, develops implementation plans and presents to BU LT for approval of implementation.
  
  
  • Provides oversight and ensures BU awareness and compliance with all processes / procedures affecting quality; e.g. new raw material acceptance, new or changes to product specifications, customer specific specification approval, etc.
  
  
  
  


• Interacts with Business Teams on quality related issues. Connects with BU R&D & Central Analytical in KoP for input on QC analytical procedures, instrumentation recommendations & input on specifications.


• Forms and leads a multi-site quality network that aligns on standardized quality processes and procedures via at least annual face-to-face meetings and monthly conference calls.

Required Education/Qualifications/Work Experience:

• B.S/B.A. degree in Chemistry or related degree with 10+ years of quality experience in manufacturing or equivalent and a minimum of two years experience with quality aspects of Organic Peroxides


• Demonstrated experience with FDA guidelines, including excellent knowledge of Drug Master File (DMF)


• Knowledge of wet chemical techniques and fundamental statistical principles


• Demonstrated experience in successful implementation of current Good Manufacturing Practices (cGMP)


• Demonstrated experience in maintaining compliance with ISO 9001 certification and other relevant standards; Lead Auditor certification preferred


• Knowledge of instrumental methods of analysis, including gas chromatography, liquid chromatography, UV-visible spectroscopy, infrared spectroscopy, atomic absorption spectroscopy


• Excellent communications and organizational skills.


• Excellent skills in MS Office; SAP preferred