Quality Control Inspector (Analytical Lab)

Job Title

Quality Control Inspector (Analytical Lab)

Requisition

JR000014378 Quality Control Inspector (Analytical Lab) (Open)

Location

Port Allen, LA

Additional Locations

Baton Rouge, LA

Job Description Summary

Job Description

The Quality Control Inspector for the analytical laboratory is responsible for assuring that activities, processes, and specific 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 such as to ensure the quality integrity of the products. The Quality Control inspector 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.

Essential Functions

• Performs chemical analysis of raw material, in-process materials, finished drug product, stability, validation, and R&D samples in accordance with OSHA, EPA, FDA, cGMP, and other appropriate regulatory requirements within the Quality Control Laboratory at the Port Allen, LA manufacturing facility.
• Performs the collection, handling, and documentation of raw materials, chemical reagents, laboratory standards, and sample vessels (handle and move compressed gas cylinders) in accordance with OSHA, EPA, FDA, cGMP, and other appropriate regulatory requirements.
• Performs the calibration and preventative maintenance of analytical instruments in accordance with OSHA, EPA, FDA, cGMP, and other appropriate regulatory requirements.
• Reviews other analysts’ work.
• Performs routine housekeeping activities; create and submit HOLD alerts, work orders, etc. as applicable.
• Performs special projects as assigned by supervisor to meet company and departmental goals.
  
  

Minimum 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)
• 2yrs+ 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.
  
  

Organizational Relationship/Scope

This position reports locally to the Quality Control Supervisor.

This position directly supports Manufacturing, Materials Management, and Quality Assurance functions.

Working Conditions

Majority of work will be in 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 but not limited to safety glasses, apron, face shield, and steel toed shoes will be required.