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
