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Enzene - QC Lab Compliance Manager

  • On-site
    • Hopewell, New Jersey, United States
  • Quality

Job description

About Our Client - Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.

Website: www.enzene.com

Position Overview
The Quality Control Lab Compliance Manager will focus on ensuring that laboratory operations meet regulatory standards and high-quality outputs, and be responsible for Stability and Sample receipt programs.

Key Responsibilities

  • Quality Control Oversight: Oversee laboratory processes and workflows to ensure they meet quality and compliance standards. Develop and manage Stability and Sample receipt programs.

  • Equipment Management: Review equipment logbooks, audit trails, preventative maintenance and calibration of equipment.

  • Handle Non-Conformities: Investigate and resolve any compliance issues which arise in the laboratories including OOS and deviations. Initiate change controls and implement CAPA as needed.

  • Conduct Audits and Inspections: Perform regular audits and inspections of laboratory practices and documentation to ensure compliance with regulatory standards.

  • Technology Transfer and Method Validation: Lead protocol/report writing and training. Support the execution in coordination with Lab Managers.

  • Training: Review and maintain training records for the department. Identify training needs and design programs to enhance staff competency. Responsible for creating and maintaining department training curriculum in QMS.

  • Team Leadership: Lead and train a team of lab compliance officers and technicians.

  • Compliance: Stay updated on industry regulations and ensure that the laboratory complies with all relevant laws and standards.

  • Data Analysis and Reporting: Review and analyse data related to lab operations and compliance to identify trends and areas for improvement. Prepare detailed reports on lab compliance activities including data integrity and present findings in department and global meetings.

Job requirements

Qualifications

  • Education: Bachelor’s Degree in a relevant field such as Chemistry, Biochemistry, Biotechnology or a related field.

  • Experience: Generally, 5-7 years of lab experience in analytical method development, validation, and transfer in the biopharmaceutical industry. 1-3 years of investigation and audit experience in compliance with regulatory standards.

  • Skills: Proficient or knowledgeable in HPLC, UPLC, Gas Chromatography, Atomic Absorption, Mass Spectrophotometry, pH, CCIT, Water Testing (TOC), Karl Fischer, CIEF, CE-SDS, ELISA and other analytical methods. Skilled in LIMS /Veeva/TrackWise/Master Control.

Physical Demands

  • This job includes sitting, standing, walking, using hands/fingers for typing and handling documents, reaching, and maintaining close vision for computer work.

  • This job functions in an open office setting using standard office equipment such as computers, phones, calculators, copiers, fax machines, and file cabinets.

  • This job may require stooping, kneeling or crouching for accessing files in lower cabinets or performing other tasks.

 

Salary Range: $94,000.00 - $131,000.00 per year

 

Benefits:

  • Health Insurance (Medical, Dental, Vision)

  • Life and AD&D Insurance

  • Disability Insurance (LTD & STD)

  • 401k Retirement Plan

  • Paid Time Off

Why Join Enzene?
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.

We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.

Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.

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