Job Description

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.

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