The Caldwell ISO Compliance Coordinator is responsible for the on-going coordination of the site’s ISO 9001:2008 Program, to include developing procedures, training plant personnel, and performing periodic audits in order to ensure the site’s certification maintenance. The ISO Compliance Coordinator is also responsible for coordinating the training of employees through the Pay for Skills Program. This role is also responsible for ensuring compliance and management of the Food Safety and Security standards for the site and the maintenance of the Drug Master File, as required. Process Improvement responsibilities include executing continuous improvement efforts for the Caldwell Operation through evaluation and assessment of current processes and configuration and the application of Lean/Six Sigma principles and tools for leading continuous improvement and process and product variability reduction.
QUALIFICATIONSDemonstrated understanding of continuous manufacturing or similar processes.
- 5 - 7 years experience in laminating, paper processing or other converting operations preferred.
- Sound knowledge of ASI/HACCP/GMP standards.
- Experience in Lean Six Sigma methodologies required.
- Rudimentary experience with quality audits and audit hosting.
- Must have ISO 9001-2008 implementation experience, including company certification.
- Proven ability to utilize structured problem solving methods to deliver results.
- Excellent oral/written communication and interpersonal skills required.
- Excellent organizations skills and attention to detail.
- Must demonstrate confidence, trust and a high level of integrity.
- Strong skills in key software programs (Excel, Word, Microsoft Project).
- Bachelor of Science degree in business, industrial engineering or other related technical field required.
- Lean/Six Sigma Certification or the ability to become certified through an accredited organization preferred.
- Conduct and support all activities in a safe and responsible manner.
- Act as ISO 9001 Quality System coordinator to ensure certification maintenance.
- Develop, revise, and maintain, with the assistance from applicable departments, ISO 9001:2008 procedures to ensure compliance with ISO regulations.
- Perform and document a gap analysis for new or revised standards and determine the effect on product.
- Lead plant-wide effort for maintaining ISO certification. Meet with management team regularly to apprise it of the status of the firm’s quality and ISO compliance, including current problems and prescribed resolution.
- Enforce compliance with internal procedures to ensure that established quality and process procedures are being followed by the appropriate personnel at all times.
- Take part in and/or lead Lean Six Sigma projects.
- Manage SOP system. Develop and implement requisite SOPs for ISO compliance and customer requirements.
- Manage and provide internal SOP and Pay for Skills training. Coordinate training across departments. Maintain training database, and ensure that employee training records are up-to-date. Ensure new employees are trained on SOPs per specific job level.
- Ensure that appropriate records are properly controlled. Manage the proper storage and filing of controlled documents.
- Ensure all requirements of the Drug Master File are met and maintained as required.
- Assist in preparation for and conducting of regulatory agency inspections and audits.
- Prioritize multiple project assignments including both daily issues and long-term projects, including Six Sigma and Lean initiatives.
- Train organization on documented procedures.
- Amend and revise programs as necessary, in order to adapt to the changes that occur in the work environment
- Develop and organize training manuals and evaluation procedures in support of the facility’s Pay For Skills program.
- Maintain an adequate Food Safety and Security Program as described by the site’s current compliance level.
- Implement and coordinate HACCP programs.
- Develop, implement and monitor cleaning practices for the facility.
- Plan promote, and organize training activities related to Food Safety and Security program requirements.
- Perform work involving the collection, compilation, entering and reviewing of shift reports for omissions and inconsistencies, and ensure data entry is complete and accurate.
ESSENTIAL JOB FUNCTIONS/COMPETENCIES
· Ability to travel up to 25 percent of the time.
· IC Core Competencies: Planning and Organizational Skills, Communication/Interpersonal Skills, Customer Focus, Action Oriented, Decision Quality, Functional/Technical Skills, Integrity and Trust, Peer Relationships, Visioning, Flexibility and Managing Change, Initiative, Flexible Work Ethic, Execution Motivation.
· Other Competencies Required: Business Acumen, Problem-Solving, Priority Setting, Interpersonal Skills