Overview
Senior Quality Engineer Jobs in Newark, NJ at Mantell Associates
Title: Senior Quality Engineer
Company: Mantell Associates
Location: Newark, NJ
Mantell Associates is currently partnered with a fully integrated CDMO with global sites, who are seeking a Senior Quality Engineer to provide experienced QA support from product development through cGMP clinical and commercial production.
Senior Quality Engineer – Responsibilities:
Oversees F&E activities in real time (QAOTF) to ensure compliance with internal procedures and global regulatory requirements are met
Provide equipment, system, and facility validation /qualification guidance and ongoing support for established / validated processes
Leading cross-functional activities, in providing approach, methodology and deliverables
Partnering with project teams to provide solutions for validation of systems following a risk-based approach
Assist in developing and reviewing validation documents with functional teams, ensuring the documentation meets compliance requirements, quality standards, and current industry expectations
Track and report status and progress of qualification activities or projects to direct manager and / or management review
Identifies root causes of problems in the production process or as a result of investigations; recommends and/or implements corrective measures
QA review and approver or risk assessments
Quality point of contact for shutdown activities
Provide Quality oversight in change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state
Perform investigations and implement corrective actions related to CAPAs and deviations
Representing Quality Engineering in an emerging industry
Regular and reliable attendance on a full time basis [or in accordance with posted schedule
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Embodies cultural values and aligns daily actions with department goals and company culture
Senior Quality Engineer – Requirements:
Bachelor’s degree required (ChE, EE, IE, ME, CS, or similar) and 5 years applicable cGMP experience in regulated industry
Exceptions may be granted for equivalent work experience or graduate degree
Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity
Knowledge of Fill Finish and Biologics production environments preferred
Familiarity working with electronic batch records
Detail oriented and strong interpersonal and verbal communication skills
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at 44 (0)20 3854 7700.
