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QC Lab Compliance Manager

Pennington, NJ 08534

Posted: 02/14/2025 Employment Type: Direct Hire/Perm Job Category: Quality and Compliance Job Number: 617605 Is job remote?: No Country: United States

Job Description


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.

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
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About Pennington, NJ

Join us in exploring exciting job opportunities in the vibrant community of Pennington, New Jersey! Nestled in the picturesque Mercer County, Pennington offers a perfect blend of small-town charm and big-city amenities. With proximity to the beautiful Rosedale Park and Mercer Meadows, it's a haven for outdoor enthusiasts. Discover local art at the prestigious Morven Museum & Garden or catch a show at the Pennington Players Theatre. Indulge in delicious cuisine at the local farm-to-table restaurants or cheer on the Trenton Thunder baseball team at the Arm & Hammer Park. Embrace the unique culture and endless growth opportunities in Pennington – the perfect place to advance your career!

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