Quality Assurance Specialist - Denver, United States - STAQ Pharma

Description

STAQ Pharma is currently hiring for a Quality Assurance Specialist to join their team for the 2nd shift here in Denver, CO.

Schedule: Monday to Friday, 2 PM to 10:30 PM

Pay: $55,000-$70,000/year

The responsibilities of this individual will include

• 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
• Develop and implement corrective and preventive actions geared toward continuous process improvements
• Support the finished product label printing and issuance process
• Write and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirements
• Provide supplier related support to production and receiving inspection team
• Other duties and tasks, as assigned

Qualifications and Education Requirements

• 2-5 years of Quality Assurance experience
• Pharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturing
• B.S. or B.A. on Sciences or a relevant field or equivalent experience
• Professional certification in Quality Engineering or Quality Auditing, preferred

Preferred Skills

• 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
• Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus