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Quality and Compliance Manager Job


Location: 

Memphis, TN, United States

Employment Type:  Regular
Category:  Production / Operations
Posting Date:  Jun 14, 2022

Arkema has established itself as France’s leading chemical producer and a world leader in specialty chemicals and advanced materials. With annual sales of €8.8 billion and 20,000 people employed in some 55 countries, the Group pursues ambitious recruitment objectives both in France and around the world. Arkema offers diverse employment opportunities in 200 job functions and professions in four major fields: industrial, R&D, business, and support functions.

Reaching far beyond your discoveries!

Regarded as one of the world’s leading innovators, Arkema has made research one of the pillars of its strategy. For example by discovering new solutions to help reduce the weight of materials, hence cut down consumption. By developing innovative thermal insulation systems that can optimize the energy performance of buildings. Or by seeking new applications for its biosourced products at the service of greater sustainable development.

Innovative and durable solutions

Our high performance products have applications in wide-ranging areas, from new generation car batteries or telephones to recyclable wind turbine blades, from adhesives for the protective backsheets of solar panels to drinking water filtration systems, from running shoes and acrylic resins with no solvent and no volatile organic compound for 3D printing to molecular sieves for portable oxygen devices used by people suffering from respiratory failure… Joining Arkema means being part of a Group enjoying sustained growth that in little more than a decade has built up an exemplary achievement record, setting high ambitions for itself and for its employees. All our job opportunities are open to people with disabilities at equal merit or with equal skill levels.

 

Division:  Hydrogen Peroxide & Derivatives                                                          Date: April 29, 2022

Location: Memphis

Title: Quality and Compliance Manager

 

Situation in organization

The Quality and Compliance Manager reports to the Plant Manager. This position has one direct report and three indirect reports.

Job dimensions

The Quality and Compliance Manager oversees the overall quality of Hydrogen Peroxide. Due to the reactive nature of Hydrogen Peroxide, product quality is a leading indicator of product safety at the plant, in storage, during transport, and for the customer. The Manager ensures that the plant maintains compliance with all FDA (drug and food), ISO, and AIMS (Arkema Integrated Management System) requirements and manages customer satisfaction, product improvements and new product introduction. The Quality and Compliance Manager is a critical interface with Electronics customers providing analysis of product quality, implications of process changes, and occasionally developing analytical methods as quality requirements increase. The Quality and Compliance Manager role includes all responsibilities of the Lab Manager, the Food Defense/Safety Team Leader, and the ISO Management Representative.

 

Key Activities and responsibilities

Quality Responsibilities (65%):

  • Investigates and resolves quality incidents (Impact) and customer complaints including root cause analysis investigations as needed.
  • Leads quality system improvements as the plant to reduce customer issues.
  • Develops and maintains API product validation documentation.
  • Manages internal quality audit program including performing Supplier Evaluation.
  • Supervises plant document control, administers document management system.
  • Develops and executes management systems improvement projects.
  • Conduct annual Management System Review.
  • Oversees Electronics Grade Quality, providing regular detailed Statistical Process Control data, and interpretation of deviations to customers. Works together with KoP Business Management to provide responsive, data-driven, analysis of product quality for the customer.
  • Develops new test methods, as necessary, or works with KoP Analytical Services to develop methods.
  • Reports monthly quality performance (KPIs).
  • Reviews MOCs impacting quality, provides guidance and feedback to other disciplines to ensure ongoing compliance to ISO and cGMP standards.
  • Responds to customer inquiries through customer service or the sales team.
  • Supports new customer qualification, completes customer surveys.
  • Implements new products and product improvements.
  • Oversees plant laboratory.
  • Review/Revise SOPs in EDMS.

Compliance Responsibilities (25%)

  • Conducts annual ISO/cGMP compliance reviews.
  • Ensures compliance to cGMP requirements and all certification requirements for drug/food products.
  • Hosts /Manages customer and regulatory (FDA, ISO, NSF, etc.) audits.

Other responsibilities (10%)

  • Serve as a coach and mentor to the department personnel.
  • Cross-functional team participation.
  • Create, deliver, or ensure quality training is completed per requirements.
  • Read company communications weekly, i.e. production advisories, emails, etc.
  • Complete scheduled periodic training on time and as required

 

CONTEXT AND ENVIRONMENT

  • This position works mainly in an office atmosphere, but is required to periodically audit process and laboratory areas.
  • Ensures the laboratory area is a safe working environment and lab personnel are aware of and adhere to all safety rules.
  • Ensures compliance of regulatory and plant safety and environmental requirements with special emphasis on Process Safety Management (PSM).
  • Ensures all HES training, standards, policies, and procedures are followed.
  • 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., Behavioral Base Safety, SafeStart, etc.).
  • Supports and promotes the reporting of all health, safety, environmental, near-miss, accident or injury incidents.

 

REQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCE

  • Bachelor degree in Chemical Engineering, Chemistry, or related field.
  • 10+ years of experience to include a minimum of 5 years of experience working in a production facility in lab operations and a minimum of  5 years of experience managing Quality Systems.
  • Experience managing FDA Drug and/or Food Defense Audits, as well as ISO 9001:2015.
  • PCQI Certification for FSMA (Food Safety Modernization Act) preferred.
  • Experienced in establishing and/or reviewing Quality Agreements.
  • ASQ Certification (CQA, Engineer, Pharmaceutical) preferred.
  • Knowledgeable in Statistical Process Control.
  • Ability to interpret/translate process changes to analytical results.

 

Demonstrated Competencies

  • Must be able to multi-task and efficiently operate in a demanding work environment.
  • Must have strong 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.

 

 

 

 

 

 

 

A designer of materials and innovative solutions, Arkema shapes materials and creates new uses that accelerate customer performance. Our balanced business portfolio spans high-performance materials, industrial specialties and coating solutions. Our globally recognized brands are ranked among the leaders in the markets we serve. Reporting annual sales of €8.8 billion ($10.4 billion USD) in 2018, we employ approximately 20,000 people worldwide and operate in close to 55 countries. We are committed to active engagement with all our stakeholders. Our research centers in North America, France and Asia concentrate on advances in bio-based products, new energies, water management, electronic solutions, lightweight materials and design, home efficiency and insulation.

Arkema Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Arkema Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence.


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