Quality Control Inspector

Quality Control Inspector
Conduct inspections, verify materials, and ensure compliance with cGMP standards for pharmaceutical manufacturing processes.

Job #135846

Manufacturing

Port Allen, Louisiana

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Talascend is currently seeking a Quality Control Inspector for a contract opportunity with our client in Port Allen, Louisiana.

Overview


The Quality Control Inspector (TEMP) is responsible for ensuring that activities, processes, and conditions related to manufacturing, processing, packing, and holding of pharmaceutical ingredients, drug products, and medical devices meet current Good Manufacturing Practices (cGMPs) and comply with applicable procedures and standards to maintain product quality and integrity.


Responsibilities

• Perform area clearances/line clearances, in-process inspections of manufacturing processes, and inspection and disposition of incoming material.
• Monitor manufacturing process performance related to SPC/SQC and compliance status of manufacturing and warehouse areas.
• Prepare and attach material quality status on materials, including labeling.
• Verify all labels after final printing is completed.
• Execute activities in accordance with production schedule and assist in production schedule planning.
• Assist in the development, implementation, and maintenance of site quality procedures, standards, and controls.
• Support the quality audit function through investigations of nonconformances or deviations and assist with corrective and preventative actions.
• Perform other tasks related to product quality and efficacy as assigned by supervisor.
• Support special projects as assigned to meet departmental goals.
• If in analytical laboratories:
  • Perform chemical analysis of raw materials, in-process materials, finished drug products, stability, validation, and R&D samples.
  • Handle and document raw materials, reagents, standards, and samples in accordance with regulatory requirements.
  • Calibrate and maintain analytical instruments.
  • Review colleagues' work.
  • Perform routine housekeeping and submit hold alerts and work orders.
  • Support special projects to meet departmental goals.

Qualifications

• Associates Degree in a technical or scientific related field required
• Bachelors Degree (preferably in a science related field) preferred
• Experience in a regulated work environment is preferred
• Quality certification (e.g., ASQ CQE, CQA) preferred
• Understanding of drug cGMPs, OSHA, EPA, and FDA regulations
• Proficient in Word and Excel
• Strong mathematical skills
• Mechanical aptitude
• Excellent oral and written communication skills
• Interpersonal and organizational skills
• Detail-oriented
• Strong teamwork ethic and collaborative approach
• Assertive in enforcing regulations, policies, and procedures
• Basic knowledge of laboratory analyzers and inspection equipment

We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.


Background Check and Drug Screen may be required.