Are you interested in joining a winning team? A team whose employees are empowered to make a difference? Our culture is one of honesty, integrity and transparency with an emphasis on safety, health and environmental performance.
On our team people are acknowledged for embracing new ideas that help create real value for customers. Let’s get there together.
INEOS has an exciting opportunity for a Quality Analyst to join our INEOS Hygienics business at our Jacksonville, Arkansas facility. This is a very visible, significant role within the Company and the Quality Assurance function. This position will report to the Quality & SHE Manager.
The responsibilities of the position include, but are not limited to, the following:
Strategy
- Support the Jacksonville Site Quality & SHE Manager and US Hygienics Asset Manager in creating and implementing company vision, values and delivery of objectives linked to the overall business plan.
- Deploy operational excellence models facilitating transformation. Identify ways the business can change/adapt to meet shifts in market/customer demand and create an agile operation across the site to ensure the business can respond quickly and efficiently.
- Contribute to the creation and implementation of best practice manufacturing vision, strategy, policies, processes, and procedures to aid and improve operational performance.
- Support decision making on operational and quality policy, planning process and strategy.
Regulatory
- Ensuring compliance with current regulations.
- Obtain and maintain ISO Internal Auditor Certification.
- Obtain and maintain GMP Internal Auditor Certification.
- Organize and lead GMP and ISO internal audits.
- Recruiting and training additional members of the internal audit team.
- Participate in external audits as necessary.
- Maintain training and knowledge of GMP program, and any FDA requirements for API.
- Assist in training plant personnel on GMP requirements.
- Review/update technical and quality procedures; Own the site Standard Operating Procedures (SOP) program for QA.
- Own the site Deviation Program and manage according to GMP standard.
- Maintain site customer complaint program, including relevant RCA/CAPAs and escalations as necessary and trend analysis.
- Maintain the QA Approved Supplier List and related change management.
- Maintain the library of Approved Specifications and Technical Drawings (bottles, labels, etc) as used by Hygienics manufacturing and QA.
- Further develop and maintain the QA training program.
- Develop and maintain quality management documentation.
Quality Control
- Ability to quickly get up to speed with the Quality Management aspect of SAP and assist in troubleshooting and support for site QM- SAP module.
- Support lab operations through ordering lab supplies, maintaining instruments, and assuring timely equipment calibrations.
- Performing regular inspections and reviews to ensure employees adhere to quality and safety policies.
- Developing and implementing quality improvement plants.
- Maintain qualification and training to be able to run all laboratory testing.
- Monitoring and reporting on all activities, processes, and procedures.
- Release/reject raw materials, intermediates, packaging, and labeling materials.
- Reviewing and sign-off of the Master batch record.
- Secondary verifying that batch was made to master production procedure without deviation.
- Completing the Master batch record checklist to ensure all documents are complete and part of the official batch record.
- Verifying final batch records, and filing/storing appropriately.
- Maintain all components of batch records such as process log sheets, charge sheets, rework sheets, specification sheets, certificates of analysis, and other paperwork as relevant to the product.
- Entering all results in SAP.
- Effectively communicate with other plant personnel to maintain the proper flow of information.
- Backfilling for the Quality Manager if needed.
- Misc. activities as assigned by the Quality & SHE Manager
SHE
Support the SHE Manager to ensure on site legal, regulatory and company compliance and promoting safety culture in line with INEOS companywide culture and Safety programs.