- Our company is looking for a Quality Specialist to ensure GMP compliance within QC.
- The person for this role will have the ability to lead projects related to systems implementation and local compliance related projects.
- This individual has a deep understanding of the Quality Control environment/testing techniques, cGMP’s and quality systems with the ability to look across the department. Normally receives minimal to no instructions on project work, and general instructions on new assignments.
Reports to: Manager, Quality Control.
Main Job Tasks:
- Lead local QC projects with the ability to plan, execute and work both within the department as well as cross functionally.
- Represent QC, coordinate and facilitate QC sub-teams to execute the site wide project for integration of the local Quality Management System to the corporate QMS.
- Write and review procedures to ensure alignment with corporate procedures.Carry out technical writing for reports as needed.
- Conduct data review as needed. Ability to investigates and conduct root cause analysis for deviations related to QC with no assistance.
- Updates and maintains trending files, and provides routine summaries of trending to support investigations.
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.Incorporates the company Way and 10 Essentials in all activities and interactions with others.
Development of People:
Knowledge, Skills and Experience:
- A Bachelor’s degree in, biological/chemistry sciences or related field with a minimum of five (5) years’ related experience or a Master’s/PhD with a minimum two (2) years of related experience. a minimum two (2) years’ experience in a project lead role is preferred
- Must be able to work independently in a team based setting and function in a rapidly changing environment while balancing multiple priorities simultaneously.
- Able to conduct system and data review.
- Experience in Quality Control is required.
- Experience with Health Authority inspections is a plus.
- Excellent analytical and writing skills are also required with the ability to author/review scientific and technical reports.