We are seeking a Quality/ Analytical Scientist to join our team!

Location: East Windsor, NJ

shift: Monday through Friday (9am-5pm)

Pay: $40-50/hr

6 month Contract to hire

Position Overview

We are seeking a dedicated QA/QC Specialist to elevate our laboratory operations by ensuring adherence to industry standards and enhancing quality protocols. This role is pivotal in fostering a culture of excellence within our laboratory environment and driving initiatives that align with regulatory requirements. This individual should also be equipped to engage in hands-on analytical work within the laboratory.

Key Responsibilities:

• Ensure laboratory functions align with current Good Manufacturing Practices (GMP) and other relevant regulatory standards (e.g., FDA, EMA).
• Create and implement robust policies and procedures that 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 pinpoint 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.

Qualifications:

Education:

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

Experience:

• At least 5 years of quality management experience in a GMP-compliant environment, ideally within pharmaceuticals or biotechnology.
• Proven audit experience and familiarity with GMP quality assessments.

Interested? Reach out to us for more details on the next steps in the application process. We look forward to hearing from you!

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Medix is acting as an Employment Business in relation to this vacancy.