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- 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
- 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
Senior Quality Engineer - California, United States - Mantell Associates
Description
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:
Senior Quality Engineer - Requirements:
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at