The Quality Assurance (QA) Senior Specialist is responsible for the development, implementation and maintenance of the quality assurance systems and functions at Leadiant Biosciences, Inc. In addition, the QA Senior Specialist works with all departments of the organization to execute the quality assurance systems. This position ensures that all processes meet current U. S. Good Manufacturing Practices (cGMP) globally (e.g., 21 CFR 11, 210, and 211, USP, ICH etc.) and provides documentation that meets the requirements of US FDA.
- Analyzes industry standards and assures continual improvement of the quality system.
- Recommends, develops, secures approval, and follows up on quality system execution.
- Provides input to decisions regarding implementation and management of the quality system.
- Review of all documents, as assigned, supporting the release of each drug product lot to ensure compliance with cGMP requirements. Assures that product or material not meeting specifications is properly investigated prior to release and/ or rejection.
- Assists with company-wide training for cGMP and other quality objectives.
- Contributes to ongoing quality improvement processes working with interdepartmental teams.
- Provides effective communication regarding issues, objectives, initiatives, and performance to plan.
- Assists with planning and conducting CMO quality audits.
- Acts as the primary QA point of contact for assigned products.
- Develops and maintains quality assurance metrics, as assigned by supervisor.
- Maintains and investigates customer complaints within area of responsibility.
- Perform investigations, when appropriate, and resolves potential product quality issues to improve efficiency.
- Monitors product consistency throughout the product lifecycle.
- Initiates, reviews, and approves deviations, change controls, etc.
Specific Job Knowledge, Skill And Ability:
- Bachelor’s degree in a natural or biological science, or equivalent. education and experience
- Knowledge of 21 CFR parts 11, 210 and 211 (cGMPs), relevant ICH Guidances, and USP compendial requirements.
- Technical writing and investigation skills, as well as ability and skill in analyzing, understanding, and presenting technical data.
- Five (5) or more years of pharmaceutical industry experience in areas of quality assurance or quality control.
- Experience with sterile and solid oral drug products.
- Strong communication skills and ability to effect action across organization functions and organizational levels.
- GMP auditing experience a plus.
Leadiant Biosciences, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster is available here: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to Jobs@leadiant.com and let us know the nature of your request and your contact information.