Quality Associate

Based out of our lab in Louisville, the Quality Associate provides support to the Hyde Analytical Laboratory for quality review of results, reports, deviations, and change controls.

This role calls upon GxP experience to develop and maintain procedures and processes in support of the Hyde GMP sample analysis program.

The Quality Associate is responsible for the day-to-day review of quality documentation, GMP results, the development of root cause analysis for deviations and is responsible for the coordination and tracking of laboratory QMS processes.

Job Duties :

• Development and maintenance of GMP processes and procedures
• Review and approval of GMP sample analysis execution records and certificates of analysis
• Assists with external audits of the laboratory, and conducts audits of vendors as needed
• Coordinates and tracks the progress and closure of deviations, change controls, and CAPAs
• Initiation, review, and approval of deviations and change controls
• Performs Root Cause Analyses (RCA) for deviations
• Attends project lessons learned meetings and ensures issues are captured for continuous improvement
• Review of equipment use logs
• Review of maintenance records in the equipment management system
• Oversight and migration of quality records into the eQMS
• Review and approval of quality and training records within the eQMS
• Review and approval of suppliers based on risk
• Quality review of equipment qualifications and associated reports
• Review of method validation protocols
• Provision of printed controlled documents for laboratory execution
• Adheres to all laboratory and safety policies and procedures

Qualifications :

• BS degree or higher in Biochemical or Chemical Engineering, Chemistry, Life Sciences, or in a relevant technological field
• 2-3 years of GMP manufacturing experience, additional GMP lab experience preferred
• Quality Assurance certification or coursework, ASQ preferred
• Experience in regulatory inspection or knowledge of regulatory inspection questions, responses, language, and behavior
• Quality training and strong knowledge of Quality events including deviations, change controls, and CAPA
• Experience participating in external audits
• Strong knowledge of GxPs, including hands-on experience
• Strong communication and presentation skills, ability to work individually or in teams
• Strong computer knowledge including Microsoft Office products
• Proficient in technical writing
• Background in laboratory instrument qualification and operation preferred

Starting compensation is $55,000 annually.

Are you looking for a meaningful career that makes a difference in the world? Consider joining the Hyde Engineering + Consulting team where you will do just that.

Hyde E+C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers can effectively and safely produce their life-enhancing and often life-saving medicines.

To read more about Hyde's culture and benefits, visit our website : www.hyde-ec.com

Hyde Engineering + Consulting is an equal opportunity, affirmative action employer.

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