Senior Quality Control Specialist

7 days ago


Denver, Colorado, United States STAQ Pharma Inc Full time
Job Overview:

As a Senior Quality Control Specialist, you will play a critical role in ensuring the quality of our finished products. You will be responsible for leading the document control program, managing training documentation, and issuing GMP documents.

Key Responsibilities:
  • Lead the document control program to ensure procedures meet CGMP requirements
  • Manage training documentation and track employee compliance with training plans
  • Issue GMP documents, including Master Batch Production Records, Room and Equipment Logs, Document Change Orders, etc.
  • Support in-process and finished product lot acceptance sampling and inspection
  • Participate in investigations and problem-solving of raw material, in-process, and finished product non-conformances with production personnel and/or supplier
Requirements:
  • Excellent independent judgement and interpersonal skills
  • Excellent mathematical, written communication, and verbal communication skills
  • Strong technical writing skills and attention to detail
  • Knowledge of and proficiency in the use of basic statistics
  • Familiarity with Good Manufacturing Practices and FDA Regulations
  • Supplier Auditing experience
  • Knowledge of ERP System
  • Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus
Salary and Benefits:

We offer a competitive salary range of $80,000 - $105,000 per year, depending on experience. Our benefits package includes medical, dental, and vision insurance, 401(k) matching, and paid time off.



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