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Form of workRegulatory Compliance Specialist - Life Sciences
IMCD US currentlyhas an opening for a Regulatory Compliance Specialist for our Life Sciences business.This role is based in our Corporate Headquarters in Westlake, Ohio.
TheRegulatory Compliance Specialist will support US operations in the review, andmanagement of regulatory governance as it affects raw material distribution andthe health & safety of its employees advising on all regulations,legislative compliance and safety standards making recommendations to improvethe health, safety, environmental, and quality program. Primaryfocus will be on supporting Life Sciences lines of business. The idealcandidate will have experience with pharmaceuticals, food or personal care.
Successful candidates will be responsible to:
Provide focus and guidance to Life Sciences lines of business and all applicable government regulations to assure compliance and provide value to both Customers and Principal Manufacturers associated with IMCD operations; standards include but not limited to:
FDA (Food and Drug Act) Inspections
FSMA, PCQI, AIB, and SQF Audits and Certifications
Quality Agreements, and standard Terms & Conditions
Import and Export regulations for product raw materials - ability to assess completeness of documents required for FDA compliance
Perform all compliance reporting requirements as they apply to products within the distribution chain.
Support in new item sourcing, providing regulatory, technical, quality, and regulatory feedback to ensure regulations can be met.
Review information on product Safety Data Sheets (SDS's) and ensure compliance to all legislative requirements with knowledge about OSHA's GHS (Classification and Labelling).
Assess information on Safety Data Sheets reviewing storage requirements ensuring that contracted 3PL and company owned warehouses can safely store the product abiding to all regulations.
Support qualification of new principal manufacturers or service providers (warehouses) as it affects the regulatory risk
Manage Emergency Preparedness Programs and ensure all facilities are in compliance with QMS policies.
Execute national EHS programs ensuring compliance to all OSHA regulations putting in additional Corrective / - Preventive measures for identified hazards to ensure that the risk has been reduced to as "As Low as Reasonably Achievable" (ALARA).
Support the Quality initiatives as required to maintain all standards including ISO9001, ACD, FSVP, GMP, GDP, etc.
Maintain and be familiar with applicable government regulations (OSHA, EPA, FSMA, FDA) and make sure they are adhered to; see to it that products within Chemical Distribution meet US Regulatory Standards including, but not limited to: TSCA (Toxic Substance Control Act) and APHIS
SARA (State Authorization Reciprocity Agreement)
Clean Air and Clean Water Acts
US California Proposition 65 (California)
State and Local specific legislation, and Importation regulations
Skills:
Professional and polite phone manner.
Desire to help internal customers with Regulatory Compliance supporting all Business Units.
Organization ability - maintain and/or improve current systems
Ability to manage and prioritize multiple simultaneous demands with professionalism
Ability to work independently - see what needs to be done and do it without prompting
Diligence to follow-up, as much as necessary, until issues and projects are resolved and persevere when obstacles, delays, and/or problems occur.
Proficiency with Microsoft Office suite and other platforms such as JDE, Salesforce, Oracle
Required Qualifications:
Bachelor's Degree in Science or related field.
3-5 years of in a Quality Assurance position
DesiredQualifications
Bachelor's Degree in Food Safety
3-5 years in QA position in Life Sciences industries including food, pharmaceuticals or personal care
Supervisory Responsibility:
This position has no supervisoryresponsibilities
Work Environment:
This job currently operates on ahybrid schedule rotating between in-office and remote work environments. Thisrole routinely uses standard office equipment.
Position Type/Expected Hours of Work:
This is a full-time position, andthe hours of work and days are Monday through Friday from 8 a.m. to 5 p.m., basedon M-W or W-F in office schedule. Additional hours may be required asneeded.
Travel:
Minimal travel is required
Other Duties:
Please note this job description isnot designed to cover or contain a comprehensive listing of activities, duties,or responsibilities that are required of the employee for this job. Duties,responsibilities, and activities may change at any time with or without notice.
IMCD US currentlyhas an opening for a Regulatory Compliance Specialist for our Life Sciences business.This role is based in our Corporate Headquarters in Westlake, Ohio.
TheRegulatory Compliance Specialist will support US operations in the review, andmanagement of regulatory governance as it affects raw material distribution andthe health & safety of its employees advising on all regulations,legislative compliance and safety standards making recommendations to improvethe health, safety, environmental, and quality program. Primaryfocus will be on supporting Life Sciences lines of business. The idealcandidate will have experience with pharmaceuticals, food or personal care.
Successful candidates will be responsible to:
Provide focus and guidance to Life Sciences lines of business and all applicable government regulations to assure compliance and provide value to both Customers and Principal Manufacturers associated with IMCD operations; standards include but not limited to:
FDA (Food and Drug Act) Inspections
FSMA, PCQI, AIB, and SQF Audits and Certifications
Quality Agreements, and standard Terms & Conditions
Import and Export regulations for product raw materials - ability to assess completeness of documents required for FDA compliance
Perform all compliance reporting requirements as they apply to products within the distribution chain.
Support in new item sourcing, providing regulatory, technical, quality, and regulatory feedback to ensure regulations can be met.
Review information on product Safety Data Sheets (SDS's) and ensure compliance to all legislative requirements with knowledge about OSHA's GHS (Classification and Labelling).
Assess information on Safety Data Sheets reviewing storage requirements ensuring that contracted 3PL and company owned warehouses can safely store the product abiding to all regulations.
Support qualification of new principal manufacturers or service providers (warehouses) as it affects the regulatory risk
Manage Emergency Preparedness Programs and ensure all facilities are in compliance with QMS policies.
Execute national EHS programs ensuring compliance to all OSHA regulations putting in additional Corrective / - Preventive measures for identified hazards to ensure that the risk has been reduced to as "As Low as Reasonably Achievable" (ALARA).
Support the Quality initiatives as required to maintain all standards including ISO9001, ACD, FSVP, GMP, GDP, etc.
Maintain and be familiar with applicable government regulations (OSHA, EPA, FSMA, FDA) and make sure they are adhered to; see to it that products within Chemical Distribution meet US Regulatory Standards including, but not limited to: TSCA (Toxic Substance Control Act) and APHIS
SARA (State Authorization Reciprocity Agreement)
Clean Air and Clean Water Acts
US California Proposition 65 (California)
State and Local specific legislation, and Importation regulations
Skills:
Professional and polite phone manner.
Desire to help internal customers with Regulatory Compliance supporting all Business Units.
Organization ability - maintain and/or improve current systems
Ability to manage and prioritize multiple simultaneous demands with professionalism
Ability to work independently - see what needs to be done and do it without prompting
Diligence to follow-up, as much as necessary, until issues and projects are resolved and persevere when obstacles, delays, and/or problems occur.
Proficiency with Microsoft Office suite and other platforms such as JDE, Salesforce, Oracle
Required Qualifications:
Bachelor's Degree in Science or related field.
3-5 years of in a Quality Assurance position
DesiredQualifications
Bachelor's Degree in Food Safety
3-5 years in QA position in Life Sciences industries including food, pharmaceuticals or personal care
Supervisory Responsibility:
This position has no supervisoryresponsibilities
Work Environment:
This job currently operates on ahybrid schedule rotating between in-office and remote work environments. Thisrole routinely uses standard office equipment.
Position Type/Expected Hours of Work:
This is a full-time position, andthe hours of work and days are Monday through Friday from 8 a.m. to 5 p.m., basedon M-W or W-F in office schedule. Additional hours may be required asneeded.
Travel:
Minimal travel is required
Other Duties:
Please note this job description isnot designed to cover or contain a comprehensive listing of activities, duties,or responsibilities that are required of the employee for this job. Duties,responsibilities, and activities may change at any time with or without notice.
