GMP Quality Assurance Associate

About the position

GMP Quality Assurance Associate needs 5+ years of GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA or Engineering. GMP Quality Assurance Associate requires: BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences Testing experience with Small Molecule Thorough technical understanding of quality systems and regulatory requirements relating to quality control laboratories Knowledge of pharmaceutical manufacturing operations. Demonstrated coaching and mentoring skills. Experience in root cause analysis. Demonstrated application of statistical skills. Demonstrated strong written and verbal communications skills. Strong attention to detail. Proficiency with computer system applications. Excellent interpersonal skills and networking skills. Ability to organize and prioritize multiple tasks. Ability to influence diverse groups and manage relationships. BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences. GMP Quality Assurance Associate duties: Assess the impact of analytical deviation investigations and changes and ensure that all appropriate records are documented and retrievable. Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product. Review and approve documents including, but not limited to, analytical procedures, change control proposals, deviations, analytical equipment qualifications, analytical methods and computerized system validations. Participate in projects to improve productivity.

Place of work