GMP Quality Assurance Associate
Job Location:
Indianapolis, IN - USA
Hourly Salary:
$ 56 - 57
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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.