Quality Assurance Specialist

2 weeks ago

Denver, Colorado, United States Staq Pharma Full time

STAQ Pharma is currently hiring for a Quality Assurance Specialist to join our team here in Denver for our 1st shift.

Job Summary:

Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company's mission and vision. Responsible for providing oversight of the Quality System; including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects.

Schedule:

Monday to Friday

6 AM until 3 PM

Duties/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
  • 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

Required Skills/Abilities:

  • 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

Education and Experience:

  • 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

Physical Requirements:

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.

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