Quality Assurance Specialist - Sustainability Job
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Employer: J-Star Research Inc
SpiderID: 14018574
Location: Cranbury, New Jersey
Posted: 6/24/2025
Wage:
Category: Science/Research
Job Code / NOC / SOC:
Job Description:
DUTIES:
- Perform facility condition assessments on energy consumption, chemical waste treatment, etc. to ensure compliance within corporate environmental, health & safety policies and government regulations.
- Conduct regular inspections to ensure compliance with sustainable regulations and certifications.
- Establish and improve quality management systems to support GMP manufacturing and testing with a focus on sustainability and quality control compliance.
- Provide strategic support in relation to sustainability and quality control for the GMP facility expansion and validation of all GMP systems.
- Provide sustainability and quality oversight for the manufacture, testing, and release of APIs and intermediates in accord with cGMP regulations and related FDA/ICH guidelines.
- Perform cost-benefit analysis for sustainability projects; review and propose changes to the plant’s policies and procedures for material and waste management.
- Establish and execute a Data Integrity Program; provide support for the management and maintenance of the SOP and document control system in relation to the quality control and sustainability activities of the facilities.
- Author, review, update, and approve sustainability and quality documents, validation protocols and reports, specifications, and procedures as needed.
- Perform facility condition assessments on energy consumption, chemical waste treatment, etc. to ensure compliance within corporate environmental, health & safety policies and government regulations.
- Conduct regular inspections to ensure compliance with sustainable regulations and certifications.
- Establish and improve quality management systems to support GMP manufacturing and testing with a focus on sustainability and quality control compliance.
- Provide strategic support in relation to sustainability and quality control for the GMP facility expansion and validation of all GMP systems.
- Provide sustainability and quality oversight for the manufacture, testing, and release of APIs and intermediates in accord with cGMP regulations and related FDA/ICH guidelines.
- Perform cost-benefit analysis for sustainability projects; review and propose changes to the plant’s policies and procedures for material and waste management.
- Establish and execute a Data Integrity Program; provide support for the management and maintenance of the SOP and document control system in relation to the quality control and sustainability activities of the facilities.
- Author, review, update, and approve sustainability and quality documents, validation protocols and reports, specifications, and procedures as needed.
Job Requirements:
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
• MS in Sustainability Management
• Must have at least two (2) years of experience in quality assurance and in drug development industry.
• Must have knowledge of environmental management, sustainability management, environmental risk management, value chain management, hazardous waste management, environmental audit, environmental data analysis, resource management, life cycle assessment, benefit-cost analysis, GMP compliance, validation documentation, lifecycle documentation, IQ/OQ/PQ, FDA regulations, GMP in Manufacturing Processing, GMP for Finished Pharmaceuticals, Root Cause Analysis, CAPA, statistical analysis, process validation and improvement
SALARY $90,000.00/year
BENEFITS: 401(k) & 401(k) matching, health insurance, dental insurance, vision insurance, paid time off.
HOURS 5 Days - 40 hours, 9:00AM to 5:00 PM
CONTACT:
[email protected]
Using subject line: QL-Quality /J-Star Research Inc.
• MS in Sustainability Management
• Must have at least two (2) years of experience in quality assurance and in drug development industry.
• Must have knowledge of environmental management, sustainability management, environmental risk management, value chain management, hazardous waste management, environmental audit, environmental data analysis, resource management, life cycle assessment, benefit-cost analysis, GMP compliance, validation documentation, lifecycle documentation, IQ/OQ/PQ, FDA regulations, GMP in Manufacturing Processing, GMP for Finished Pharmaceuticals, Root Cause Analysis, CAPA, statistical analysis, process validation and improvement
SALARY $90,000.00/year
BENEFITS: 401(k) & 401(k) matching, health insurance, dental insurance, vision insurance, paid time off.
HOURS 5 Days - 40 hours, 9:00AM to 5:00 PM
CONTACT:
[email protected]
Using subject line: QL-Quality /J-Star Research Inc.
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Experience: 2
Education: Masters
Travel:
Vacation:
Contact Information:
| Contact Name: KAYLA YU | Type: |
| Company: J-Star Research |