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Quality Assurance Associate Consultant

2 months ago

Marquand, Missouri, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Quality Assurance Associate Consultant to join our team at BioSpace, Inc. This role is responsible for ensuring the laboratory maintains a state of control with regards to the generation and reporting of analytical data.

Key Responsibilities
  • Provide QA oversight for PR&D, PR&D CPs, and PR&D GMP Service Providers as required.
  • Ensure that appropriate Quality Systems are in place and are being utilized, facilitating quality improvement initiatives and the implementation of new quality standards.
  • Evaluate potential impact of incidents on the quality of materials or the integrity of data, ensuring appropriate investigations are conducted for deviations, stability failures, and out-of-specification results.
  • Perform Quality Assurance review and/or approval/rejection of GMP documentation, ensuring compliance with internal standards and applicable regulations.
  • Be available for consultation on quality-related issues as needed.
Requirements
  • Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or Engineering, or equivalent experience.
  • Experience in Quality Assurance/Control, Technical Services, Laboratory, Development, or Manufacturing desirable.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.