Quality Assurance Specialist

STAQ Pharma

STAQ Pharma

Quality Assurance
Columbus, OH, USA
Posted on Saturday, June 3, 2023
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STAQ Pharma is currently hiring for a Quality Assurance Specialist to join their team for the 1st shift here in Columbus, OH.

Schedule: Monday – Friday, 6 AM to finish

BENEFITS: We provide medical, dental & vision insurance, as well as a 401K, Life insurance, voluntary life insurance, long term and short term disability, HSA & FSA, Aflac, LegalShield & IDShield, pet insurance, MetLife & SupportLinc Employee Assistance (mental health support)

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

Additional Notes

This position will work closely with the Production team and report quality data to the department head, as needed