Quality Control Specialist

1 day ago

Port Allen, Louisiana, United States Mallinckrodt Pharmaceuticals Full time
Job Title: Quality Control Inspector

Job Summary:

The Quality Control Inspector is responsible for ensuring that activities, processes, and conditions related to the daily manufacturing, processing, packing, and holding of active pharmaceutical ingredient (API), drug product, and medical devices meet current Good Manufacturing Practices (cGMPs) and comply with applicable procedures and standards.

Key Responsibilities:

  • Perform chemical analysis of raw materials, in-process materials, finished drug product, stability, validation, and R&D samples in accordance with OSHA, EPA, FDA, cGMP, and other appropriate regulatory requirements.
  • Collect, handle, and document raw materials, chemical reagents, laboratory standards, and sample vessels in accordance with OSHA, EPA, FDA, cGMP, and other appropriate regulatory requirements.
  • Perform calibration and preventative maintenance of analytical instruments in accordance with OSHA, EPA, FDA, cGMP, and other appropriate regulatory requirements.
  • Review other analysts' work and perform routine housekeeping activities.
  • Perform special projects as assigned by supervisor to meet company and departmental goals.

Requirements:

  • Associate's Degree in a technical or scientific field.
  • Strong mechanical aptitude and familiarity with laboratory analyzers and inspection equipment.
  • Excellent teamwork and communication skills.
  • Preferred: Bachelor's Degree in a science-related field, 2+ years of experience in a regulated work environment, quality certification, knowledge of drug cGMPs, OSHA, EPA, and FDA regulations.

Working Conditions:

Majority of work will be in a manufacturing environment, with some work performed in an office setting. Will be required to sit or stand for long periods of time, work with chemical reagents and compressed gas cylinders, and lift, push, or pull up to 50lbs. Use of personal protective equipment (PPE), including safety glasses, apron, face shield, and steel-toed shoes will be required.

Mallinckrodt Pharmaceuticals is an equal opportunity employer.

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