Quality Control Specialist

2 weeks ago

Port Allen, Louisiana, United States Mallinckrodt 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 ingredients, drug products, and medical devices meet current Good Manufacturing Practices (cGMPs) and comply with applicable procedures and standards. This role performs functional and analytical assessments at the Port Allen, LA facility to ensure safe and effective products, complying with government regulations, guidelines, and company policies.

Key Responsibilities:
  • Perform chemical analysis of raw materials, in-process materials, finished drug products, stability, validation, and R&D samples in accordance with OSHA, EPA, FDA, cGMP, and other regulatory requirements.
  • Collect, handle, and document raw materials, chemical reagents, laboratory standards, and sample vessels in accordance with OSHA, EPA, FDA, cGMP, and other regulatory requirements.
  • Calibrate and perform preventative maintenance of analytical instruments in accordance with OSHA, EPA, FDA, cGMP, and other regulatory requirements.
  • Review other analysts' work.
  • Perform routine housekeeping activities and create and submit HOLD alerts, work orders, etc. as applicable.
  • Perform special projects as assigned by supervisor to meet company and departmental goals.
Requirements:

Education / Experience / Skills:
  • 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 Skills:
  • Bachelor's Degree (preferably in a science-related field).
  • 2+ years of experience in a regulated work environment.
  • Quality certification preferred (e.g., ASQ CQE, CQA).
  • Knowledge of drug cGMPs, OSHA, EPA, and FDA regulations.
  • Collaborative and tactful in interacting with all organizational levels.
  • Assertive in enforcing regulations, policies, and procedures.
Working Conditions:

This position reports locally to the Quality Control Supervisor. The 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.

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