Enzene Biosciences Ltd · 4 hours ago
Associate, Raw Material
Pennington, NJ
Full-time
Onsite
Entry Level
1+ years expEnzeneinc is a company focused on quality control within the pharmaceutical industry, and they are seeking a QC Raw Material Associate. The role involves assisting with material inspection, sampling, and documentation to ensure compliance with company specifications and regulatory standards.
BiotechnologyDeliveryManufacturing
Responsibilities
Participate and support the inspection, sampling and testing of incoming raw materials and consumables
Review all material related documentation including supplier documents, specifications and results
Author material specifications and assist with document lifecycle
Support Material Qualification Program by tracking material metrics
Ability to participate when management is conducting risk assessments and implement risk mitigation strategies for raw materials
Comply with the process related to incoming raw materials and consumables, compile associated data, maintain accurate records and tracking of materials
Work to help identify and resolve any material related issues by assisting with investigations for out of specification results and deviations
Support continuous improvement initiatives to optimize raw material testing and release
Working with management, to revise content as needed and participate in training required personnel to ensure they are well versed in raw material and consumable test methods
Review and revise documentation related to procedures, specifications, risk assessments, protocols and summary reports as requested by management
Provide support for all raw material QMS documents including material specifications, certificate of analysis and change control deliverables
Participate in coordinating the management and storage of raw material/consumable testing data, review to ensure it is accurate, securely stored and easily retrievable
Analyze data to identify trends and propose areas for improvement
Continuously work with client and audit management to enhance skills and knowledge regarding raw material/consumables for regulatory and client audits for GMP compliance
Other duties as assigned
Qualification
Required
An associate's degree in relevant fields such as Microbiology, Chemistry, Biochemistry, Biotechnology, Engineering or related discipline
1-2 years of progressive experience within pharmaceutical or biotechnology industries, raw material testing, and release
Experience working in a Good Manufacturing Practice (GMP) and Good Laboratory Practices (GLP) environment
Proficiency in quality control software including LIMS and data analysis tools
Ability to adhere to cGMP sampling and testing procedures in compliance with internal SOPs and relevant cGMP guidelines
Strong verbal communication skills and documentation skills required
Must be able to speak clearly to convey information to others
Timely follow-up and response is required
Preferred
Advanced degrees are often preferred
Understanding of compendial test procedures and methods is preferred
Familiarity with Microsoft Office applications and an understanding of electronic documentation or laboratory systems (e.g., LIMS, cGMP-compliant tools) is desirable
Benefits
Health Insurance Medical, Dental, Vision
Life and AD&D Insurance
Disability Insurance
401k Retirement Plan
Paid Time Off (Vacation, Sick Leave, Holidays)
Company
Enzene Biosciences Ltd
Enzene an integrated global CDMO offers services spanning discovery, development and commercial supply.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$50.26MKey Investors
Alkem Laboratories,Eight Roads Ventures India,F-Prime
2023-01-30Series Unknown· $50.26M
Leadership Team
Lourdes Gonzalez-Novo, MBA
Chief Commercial Officer (CCO)
Recent News
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