Quality Assurance Specialist – Sustainability Position Available In Middlesex, New Jersey
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Company:
J-Star Research
Salary:
$90000
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.
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.
WORK LOCATION
6 Cedarbrook Drive, Cranbury, NJ 08512
