Quality Manager (Salary Range: $102,200 - $132,700) Job

Job Summary:

Responsible for direct customer liaison as related to the daily operation of the Quality Control Lab.  Ensures efficient management of all Quality Systems.  Responsible for developing and maintaining robustness in the quality system to comply with ISO standards, 9001, 45001, and 22000. Responsible for the maintenance of the analytical control of the lab methods and corrections, specialized product testing and upkeep of analytical instrumentation.

Management Systems (30 %)

• Serve as contact for all quality related audits (ISO 9001, ISO 22000, FSSC, etc.) monitor the efficiency of the quality system by performing internal audits at regular intervals.
• 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).
• Maintain a system for monitoring regulatory requirements and trends, including QA related issues within the industry.

Complaints/Off-spec (15 %)

• Lead the coordination and or investigation of all customer complaints.
• Manage non-conforming product system.

Lab & Data Management (40%)

• Oversee all quality control activities, including materials, in-process testing, and final product testing.
• Install and maintain data in SAP and LIMS systems.
• Coordinate special analytical requests of Operations, Technical, R&D, sales and Marketing.
• Develop analytical and standard operating methodology as needed.
• Ensure all laboratory facilities, instruments and inventory are maintained in an efficient and safe manner.
• Identifies opportunities for process improvement and cost reduction by using statistical analysis.  Implements best practices to enhance product quality and efficiency.

HR / Safety (15%)

• Fosters a culture of teamwork, accountability, and continuous improvement within the quality control team.
• 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.

Minimum Qualifications and Education Required:

• 10 years of quality experience to include 5 in manufacturing environment with lab operations and 5 years managing quality systems.
• BA/BS in Chemical Engineering, Chemistry, or related field.

Competencies/Knowledge Sills & Abilities

• Excellent organizational, interpersonal, and communication skills.
• High level of detail and accuracy required.
• Must possess high functional and/or technical knowledge and skills in areas of responsibility. 
• Knowledge of instrumental methods of analysis, including gas chromatography, liquid chromatology, UV-visible spectroscopy, infrared spectroscopy, atomic absorption spectroscopy
• Knowledge of wet chemical techniques and fundamental statistical principles
• Excellent skills in MS Office; SAP preferred

Health & Environmental Safety (HES) Requirement: 

• Supports the site HES policy and complies with all regulatory and internal requirements.
• Participates in HES activities provided by site management and Arkema Inc. (e.g., CARE (Behavioral Based Safety), Smart, etc.)
• Supports and promotes the reporting of all health, safety, environmental, near-miss, accident or injury incidents.

 Physical Demands/Working Conditions:

• Work is performed primarily in a lab setting with frequent interruptions and distractions; maybe regularly exposed to fumes or airborne particles and toxic or caustic chemicals; the employee is frequently exposed to risk of chemical hazards, explosive hazards, burn hazards and electrical shock. The noise level in the work environment is usually moderate.
• Ability to wear required Personal Protective Equipment
• Sufficient physical ability and mobility to work in an lab setting; must be able to stand or sit for prolonged periods of time, occasionally stoop, bend, kneel, crouch, reach, and twist; to lift, carry, push, and/or pull up to 25 pounds;
• Must be able to operate office equipment requiring repetitive hand movement and fine coordination including use of a computer keyboard; and to verbally communicate to exchange information

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