STAQ Pharma is currently hiring for a Quality Assurance Specialist to join their team for our 1st and 2nd shift here in Denver, CO.
Schedule:
Monday - Friday,
6 AM to 2:30 PM
Monday - 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
Must be able to read and write in English
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
Additional Notes
This position will work closely with the Production team and report quality data to the department head, as needed