|General Position Summary
This position is responsible for coordinating product regulatory compliance for MCA (Mitsui Chemicals America, Inc) by understanding and adhering to the MTP (Mid-Term Plan) and Budget following the corresponding MCI (Mitsui Chemicals, Inc) Division’s strategy and policy, ensuring Federal, State and Local government regulatory compliance for chemical substances. And this position is also responsible for establishing, implementing and maintaining quality management procedures and systems for all of MCA products by closely communicate and consulting with QA/RC Manager.
Essential Job Functions
Primary Job Functions
Assist the department manager in providing guidance and leadership across multiple businesses.
- by understanding the strategy and policies of MCA and corresponding MCI Division;
- by clarifying the department’s mission;
- by analyzing the strengths and weaknesses of MCA;
- by identifying barriers to success while taking into consideration of risk analysis and presenting to QA/RC Manager for proposals-
- by gathering information, and analyzing the internal and external business environment, including markets, customers, suppliers and trends of regulation, guidance and best practices which pertains to chemical substances;
- by supporting strategies for Quality System processes and supporting technology, and ensuring the integrity, consistency, and harmonization of these processes and systems for MCA;
- by applying ability to utilize technological tools (e.g., PC's, software, systems, programs, web sites) and business system applications to manage, synthesize, and interpret data relevant to workloads, responsibilities, problem identifications and resolutions;- by collaborating strategy, measures, and targets with the department;
- and by leveraging available resources, including HR, materials, and finances.
Adhering to MTP and Budget for QA and Regulatory Compliance
- by achieving the objectives of the plan, accountability for the results, and explaining them to team members and MCA Senior Management
- by maximizing profit for MCA;
- by making informed decisions in authorized areas;
- by receiving opinions, and proposals from colleagues;
- and by working as a team member.
Regulatory Compliance Support-70%
- by acting as the Compliance Specialist;
- by applying skill and ability to work with sensitive information, safeguarding confidential information and working with it objectively;
- by coordinating and managing MCA and MCI compliance activities with department management
- by communicating with MCI to improve the compliance system and having communications with various Federal, State, and Local government regulators;
- by monitoring and studying new and existing EPA, FDA, TSCA, DOT (HAZMAT), OSHA regulations, U.S. and International Food Contact Status and other regulations;
- by collecting, organizing, synthesizing, and analyzing data; summarizing findings; developing conclusions and recommendations from appropriate data sources and relaying all information on regulations to MCA;
- by drafting and finalizing declarations of compliance based on the customer quality/regulatory request within Voice of Customer system in a timely manner;
- by attending, webinars, seminars or classes as necessary;
- by providing information about the development and changes of regulations that may affect MCA business;
- by supporting Company compliance direction, guidance, and procedures for all MCA and MCI Staff;
- by maintaining records of compliance, including issuing & maintaining SDS’s;
- by coordinating plans for audits, follow up on notices of violation, and by registering materials with the U.S. government as necessary.
Quality Assurance Support-30%
- by implementing quality management policies, procedures, and systems for all of MCA products;
- by minimizing claims and complaints from customers by continually improving the Quality Assurance system;
- by monitoring raw material and product conformity to specifications and maintaining production and customer specifications;
- by receiving customer claims and complaints, finding and analyzing root causes with excellent communication skills with customer or Manufacturing Plants oriented attitude, through a cross-functional team approach, co-working with Director of Production
Technology when it pertains to Admer, establishing both short term and mid to long term countermeasures and submitting timely an official report to the customer to close
- by taking corrective and preventative action for nonconforming products;
- by making periodic audit for procedures and systems to maintain the product’s quality internally and externally;
- by receiving, investigating and responding all the requests from customers for quality surveys, industry requirements, and regulation related inquiries such as food safety (FDA), car industries (PPAP), etc. and retaining all the records with customers;
- by ensuring the proper handling and disposing of merchandise and in Admer’s case, in consultation with Department & Technical Managers;
- and by managing decisions regarding irregular occurrences including accidents, legal violations, and any other problems in coordination with department management.
*Ideal candidates are experienced with interpreting quality guidelines, regulatory requirements and demonstrate strong technical abilities along with well-developed leadership skills. The candidate must have a working knowledge of quality management systems, manufacturing, regulatory compliance, internal/external auditing and the ability to engage and collaborate with stakeholders to drive improvements.
Job Type: Full-time
To apply for this position, please submit your resume to : email@example.com