Senior Quality Assurance Laboratory Manager

3 days ago


Cranbury, New Jersey, United States Medix Full time

Job Description:



We are seeking a Senior Quality Assurance Laboratory Manager to join our team in East Windsor, NJ.



Company Overview: Medix is a leading provider of staffing solutions in the life sciences industry.



Job Responsibilities:





  • Develop and implement quality assurance strategies to ensure compliance with current Good Manufacturing Practices (GMP) and other regulatory standards.

  • Create and maintain robust policies and procedures to uphold GMP compliance throughout the laboratory.

  • Manage quality control initiatives to guarantee the integrity and reliability of laboratory results.

  • Conduct regular audits to assess compliance and identify areas for enhancement.

  • Design and facilitate GMP training sessions to equip staff with essential knowledge of quality regulations and standards.

  • Oversee the lifecycle of GMP-related documentation, including Standard Operating Procedures (SOPs), protocols, and reports.

  • Ensure meticulous documentation of deviations and the management of corrective and preventive actions (CAPAs).

  • Identify potential quality risks within laboratory operations and implement effective mitigation strategies.

  • Lead root cause investigations for quality-related issues, ensuring actionable solutions are developed and followed through.

  • Prepare for and manage external audits, ensuring readiness and effective follow-up on findings.



Requirements:





  • Bachelor's degree in Chemistry, Biology, or a related scientific discipline.

  • At least 5 years of quality management experience in a GMP-compliant environment, preferably within pharmaceuticals or biotechnology.

  • Proven audit experience and familiarity with GMP quality assessments.



Salary: $40-50/hr



Location: East Windsor, NJ



Contract Type: 6-month contract to hire



If you are a motivated and detail-oriented professional looking to advance your career in quality assurance, please do not hesitate to reach out to us for more information on this exciting opportunity.



#MedixNE



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