Sr QA Associate

Avara Pharmaceutical Technologies Inc-posted 3 months ago

Full-time

Norman, OK

501-1,000 employees

Resume

Match Score

Upload and Match ResumeTrack Jobs with Teal

The position involves reviewing and approving batch records, deviation investigations, and reports. It provides inter- and intradepartmental support in the preparation and review of documentation related to manufacturing processes, equipment, and computer systems that affect GMP-related activities. The role administers the QA deviation and CAPA system, internal audit system, supplier audit system, and all other necessary quality systems while providing GMP guidance to other departments and project teams.

Assist in the investigation, reporting, and resolution of major deviations
Review and approval of validation protocols and reports
Review and approval of all GMP document revisions including SOP's, MPR's, specifications, test methods, etc.
Administration of the deviation and CAPA system
Administration of the internal audit and supplier audit program
Performance of internal and external audits
Host and support for audits of APT by third parties, Avara corporate, and all regulatory bodies
Review and approval of CAPA plans and completion
Follow up on CAPA and deviation to ensure effectiveness
Representation of QA on site-wide and regional and global project teams
Provide GMP guidance to all affected departments at APT
Development and preparation of all QA metrics and reporting the results to APT and regional and global management (Q10)
Development and administration of APT OJT and GMP training program
Use of statistical analysis tools to evaluate data
Development and use of risk assessment tools

3-5 years previous experience with GMP within the pharmaceutical industry
3-5 years direct QA experience
Good verbal and written communication skills with basic computer skills
Attention to detail and accurate record keeping
Able to multi-task
Basic understanding and knowledge of GMPs and the pharmaceutical industry, quality practices and standards
Experience with statistical data analysis preferred
Must be able to read, write and understand the English language
Must be able to work independently with some supervision
Must be able to gather and evaluate data to make sound decisions
Must be able to exercise judgment in the resolution of problems
Office environment; must be able to sit at a desk for extended periods of time
Occasionally requires ability to climb stairs and the ability to perform while wearing required personal protective equipment, such as respiratory protection, eye protection, hearing protection and safety shoes
Knowledge of CFR parts 210 & 211
Experience with Microsoft programs (Excel, Word, etc.)

Bachelor’s degree

Track Jobs with Teal

Job Search Resources

•

Resume Builder

•

Resume Examples

•

Cover Letter Examples

Sr QA Associate

Job Search Resources

Tools

Career Hubs

Guides

Company