A Quality Control Analyst is required to possess a robust understanding of quality system requirements including 21CSR820, ISO 9001, and ISO 13485, complemented by practical knowledge of lean manufacturing and Six Sigma. This role demands proficiency in Microsoft Office Suite, especially Excel and PowerPoint, along with experience in developing and executing test plans using various testing techniques. The ideal candidate should be detail-oriented, capable of multitasking in a team environment, and adept at thriving in a fast-paced, growing company.
Summary of Quality Control Analyst Knowledge and Qualifications on Resume
1. BS in Industrial Engineering with 4 years of experience
Experience in chemistry with interests in the dental field.
Knowledge of GMP/medical devices ISO13485/MDR/Quality Systems.
Experience in cell therapy with setting up and successfully managing cell-based assays.
Must have SAP knowledge (QM module).
A customer- and quality-orientated person.
Solid understanding of 5S/Kaizen methodology.
Ability to manage independently your daily tasks/goals.
Strong relationship-building and conflict-resolution skills.
A real team player who easily communicates with all stakeholders.
Ability to write reports with good computer skills including Word, Excel, and PowerPoint.
2. BS in Biochemistry with 2 years of experience
Experience with a focus on areas of science, engineering, and/or business administration in manufacturing.
Understanding of Quality System Requirements, 21CSR820, ISO 9001, and ISO 13485.
Practical knowledge of lean manufacturing, Six Sigma, and team problem-solving.
Excellent oral and written communication skills.
Detail-oriented, team player, and the ability to multi-task.
Microsoft Office Suite skills including Excel and PowerPoint.
Experience working in creating test plans and executing them.
Experience with a variety of different testing techniques.
Knowledge of Internal Audit Testing or Quality Control.
Ability to thrive in a fast-paced growing company.
3. BS in Mechanical Engineering with 3 years of experience
Experience working in Chemistry or Biological Sciences.
Knowledge of Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework.
Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia, and guidance documents.
Experience with FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
Ability to work independently and as part of a team.
Proficient in MS Office, Visio, Project, and statistical software.
Ability to effectively work in a fast-paced, start-up environment.
Excellent organizational skills and an ability to prioritize effectively.
Good verbal and written communication in the collaborative work environment.
Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.