Associate, Raw Material

Enzene INC•Pennington, NJ

4h•$26 - $32

About The Position

The QC Raw Material Associate will be primarily responsible for assisting with material inspection, sampling, data entry and documentation of incoming materials to ensure they meet company specifications and regulatory standards. Along with supporting investigations, material qualifications and requires strong attention to detail and communication skills.

Requirements

Education: An associate’s degree in relevant fields such as Microbiology, Chemistry, Biochemistry, Biotechnology, Engineering or related discipline. Advanced degrees are often preferred.
Experience: 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 is crucial. Proficiency in quality control software including LIMS and data analysis tools.
Skills: Ability to adhere to cGMP sampling and testing procedures in compliance with internal SOPs and relevant cGMP guidelines. 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.
Communication: 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.

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 cClient and audit management to enhance skills and knowledge regarding raw material/consumables for regulatory and client audits for GMP compliance.
Other duties as assigned.