Position Purpose:
The Quality Assurance (QA) Specialist is responsible for the execution and maintenance of the quality assurance systems and functions at Leadiant Biosciences, Inc. In addition, the QA Specialist works with all departments of the organization to execute the quality assurance systems. This position ensures that all processes meet current Good Manufacturing Practices (cGMP) globally (e.g., FDA, EU, etc.) and provides documentation that meets the requirements of global regulatory bodies.
Essential Functions:
- Analyzes industry standards and assures continual improvement of the quality system. Recommends, develops, secures approval, and follows up on quality system execution.
- Review of all documents supporting the release of each drug product to ensure compliance with cGMP requirements. Assures that product or material not meeting specifications is properly investigated prior to release and/ or rejection.
- Maintains the Document Management System(s).
- Initiate and review deviations, change controls, etc.
- Maintains corporate training for cGMP and other quality objectives.
- Maintains quality assurance metrics for performance improvements of all teams.
- Participates in investigations, when appropriate, and resolves potential product quality issues to improve efficiency.
- Maintains and investigates customer complaints within area of responsibility.
- Implements ongoing quality improvement processes working with interdepartmental teams.
- Maintains product consistency throughout the product lifecycle.
- Provides effective communication regarding issues, objectives, initiatives and performance to plan.
- Maintains internal and external audit schedules.
Specific Job Knowledge, Skill And Ability:
- Bachelor’s degree in chemistry, biology, engineering, or o ther related field.
- knowledge of 21 CFR parts 11, 210, and 211, cGMPs, EU GMPs, ICH Guidance and compendial requirements.
- Technical writing and investigation skills, as well as ability and skill in analyzing, understanding, and presenting technical data.
- 3 – 5 years of pharmaceutical industry experience in areas of quality assurance
- Experience with sterile drug products and biopharmaceuticals preferred
- Strong communication skills and ability to drive action across organization functions and organizational levels is expected.
- 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.
