Quality Assurance Manager

Company:

INEOS Oxide

Interested in joining a winning team? A team whose employees share in the ownership of the business and are empowered to make a difference?

Job Title

Quality Assurance Manager

Location

Plaquemine, LA

Operating Unit/Strategic Unit

Quality / Lab

INEOS Oxide USA

Organizational context and job purpose

INEOS Organization:

INEOS is a global manufacturer of petrochemicals, specialty chemicals and oil products. It comprises 15 businesses each with a major chemical company heritage. Its production network spans 65 manufacturing facilities in 16 countries throughout the world. INEOS products make a significant contribution to saving life, improving health and enhancing standards of living for people around the world. Its businesses produce the raw materials that are essential in the manufacture of a wide variety of goods: from paints to plastics, textiles to technology, and medicines to mobile phones - chemicals manufactured by INEOS enhance almost every aspect of modern life.

BUSINESS CONTEXT:

The INEOS manufacturing complex consists of three world-class manufacturing plants; ethanolamines, polyglycol and glycol ethers. Collectively, all three plants produce over 500 million pounds per year with sales revenue in excess of $250 million per year.   Two of these plants, the polyglycol and glycol ethers plant, are contract manufactured for The Dow Chemical Company. 

A staff of sixty INEOS employees and forty contractors operates the manufacturing plants continuously.  With the exception of supplying raw materials, utilities and some technical support, all activities are handled by the staff at the Plaquemine plant.  These activities include reaction, distillation/finishing, process control, packaging, loading, quality control/quality assurance, maintenance, safety, environmental, and supply chain activities.

Purpose of the Job:

The Quality Assurance Manager oversees the activity of quality assurance including staff, developing, implementing, and maintaining a system of quality and reliability testing for the overall site’s products and/or development processes. 

Environment / Context:

• The Quality Assurance Manager position reports directly to the Technical Services and Quality Manager
• Position leads and manages QA personnel to support defined business objectives while interfacing daily with operations, engineering, SHE, quality control, and commercial/business personnel to prioritize activities to meet the performance goals

Responsibilities and Accountabilities

Accountability 1: 

SHE

Most important activities

• This position – and all positions – with the INEOS Oxide US organization requires that the incumbent commit to learning, following, and practicing INEOS 20 Principles of Process & Behavioral Safety as applicable to the position.  These Principles are posted throughout each Oxide facility and each employee must also commit to following INEOS’ Life-Saving rules on a daily basis.  These are also posted within each Oxide facility.
• Maintain safety as the highest priority of the plant
• Adhere to and uphold all safety policies and standards Routinely collect, report, and address SHE near misses
• Actively participate in and support overall SHE processes

Accountability 2: 

Quality Management Systems

Most important activities

• Guides organization for all aspects of the quality standards (ISO, Good Manufacturing Practices (GMP)) in support of both INEOS and Dow products
• Shared responsibility with Quality Manager for evaluation of significance of changes to be implemented in pharmaceutical excipient producing plants (GMP)
• Manage the following activities: 
  • Personnel and personnel development for Quality Assurance
  • Lotting/release of product, retain management, batch record reviews, risk assessments, control program
  • Action item program for Plaquemine site
  • Internal/External Quality Audit coordination (customers, internal, registrar, supplier) and Internal Audit Program
  • Audit response collection and submission to appropriate party and entry into CAPA system
  • Manage the QM database and QN database for INEOS and Dow
  • Quarterly product quality reviews
  • Annual typical reviews for both Dow and INEOS products
  • INEOS specification database with updates provided by INEOS Product Stewardship
  • All plant quarterly and special 3rd party testing submission program/ results tracking
  • Updates on Quality procedures (tier 1, 2, 2.5)
  • ISO/GMP registration and external audit by registrar
  • Coordinate completion and investigation of out of specification (OOS) forms, ensuring all sections properly completed and ready to log file
  • Quality Liaison with Dow Quality personnel and quarterly review of Dow quality
• Determination of disposition of nonconforming final
• Share with TS/Quality Manager responsibility to conduct / coordinate Quality Risk assessments, Develop / execute validation plans as required to support the 2 GMP plants
• Ensure Analytical methods in use by the lab are current/ provide compendial or ASTM revisions to lab supervisor for implementation/ validation as required.
• Ensure CPK reports and evaluation are performed and communicated on a predetermined basis monitoring inbound DOW and INEOS raw material quality (QM)
• Coordinate and manage EOA internal quality waivers process

Accountability 3: 

Quality Audits and Reviews

Most important activities

• Internal/External ISO and GMP Quality Audit coordination (customers, internal, registrar, supplier) and Internal Audit Program
• Audit response collection and submission to appropriate party and entry into CAPA system
• Participate in Production led Quarterly product quality reviews
• Schedule Annual Typicals reviews with Plant engineers
• Coordinate and manage EOA internal quality waivers process
• Perform vendor quality audits at a minimum as scheduled by Technical Services
• Audit and ensure functioning EOA and PEG batch record review program

Accountability 4: 

Personnel Management and Development

Most important activities

• Provide direct supervision and development of Quality Assurance Chemist and Document Controller
• Provide personnel evaluation and support for all direct reports and assist with personnel support of indirect reports including regular coaching/feedback
• Conduct succession planning for area of responsibility

Skills/Competencies

Education/Experience

• Bachelor’s degree in a science-related discipline required, preferably Chemistry
• PhD preferred / helpful
• Minimum of 7 years of progressive Quality and Laboratory experience in a continuously operating manufacturing environment
• Successful candidate must possess 3-5 years of direct supervisory experience directing the work of a cohesive team.  The ability to inspire, motivate and clearly communicate the company’s vision and mission to subordinates is a must.

Technical Skills

• Strong technology skills, including proficiency with SAP system, and ability to learn and stay abreast of industry changes. 
• ISO 9001: 2015 / IPEC or EXCiPACT cGMP comprehension required. 
• Auditor certification strongly preferred.
• Strong contacts with key vendors, universities, professional associations
• Strong organizational and project management skills
• Understanding of business, process development, and legal challenges and expectations.

Behavioral Skills

• Able to work in fast-paced and growing environment
• Motivated, self-starter who desires success
• Responsive to questions and needs in a deadline driven environment
• Excellent analytical and problem solving skills
• Ability to work in a team environment, and leverage additional resources as needed
• Demonstrate flexible and efficient time management and to appropriately prioritize workload based upon organization needs
• Strongly developed interpersonal, leadership, and communication skills.
• Proven ability to lead diverse groups of people successfully.
• Possesses a track record of accomplishment in leading roles by driving accountability.

ADA Physical requirements, visual acuity requirements and environmental conditions

Inside

Sedentary Work:  Exerting up to 20 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.  Sedentary work involves sitting most of the time.  Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

The worker is subject to both environmental conditions that occur inside and outside.

Outside

The worker is subject to atmospheric conditions:  One or more of the following conditions that affect the respiratory system or the skin:  fumes, odors, dusts, mists, gases, or poor ventilation.

Candidates must be fully vaccinated against COVID-19.

PERFORMANCE INDICATORS

Following are the Primary Key Performance Indicators for this position:

• No quality release of off-spec product
• SHE Performance: Zero incidents
• Departmental Goals & Objectives ≥ 99%
• 100% compliance:
• EPA
• GMP
• ISO
• DOT
• OSHA
• Meet all departmental annual training and progression goals: individual and direct/indirect reports as defined in annual performance assessment

Our culture is one of honesty and integrity with an emphasis on safety, health and environmental performance.On our team, people are acknowledged for embracing new practices that help create real value for customers.