MCS Quality Assurance Specialist

Overview

Target PR Range: 36-46/hr DOE. This position supports Quality Assurance program under the ATO Plant Quality Assurance organization providing oversight of Commissioning, Qualification, and Validation (CQV) processes in Cell Banking, Drug Substance, Drug Product Filling, Drug Product Packaging/Labeling, General Utility, and Quality Control GMP areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of CQV related processes, procedures, and use of quality systems.

Primarily responsible for ensuring adherence to equipment and computer validation standards and procedures. Responsibilities include participation in CQV design, review of test protocols, analysis of CQV results, and oversight of summary reports. Provides guidance and sets standards in producing quality documentation and serves as an advisor to Engineering, IS and Manufacturing functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT compliance issues.

Executes quality oversight directly in Quality systems.

• Participate in CQV design, review of test protocols, analysis of CQV results, and oversight of summary reports.
• Provide guidance and set standards in producing quality documentation.
• Serve as an advisor to Engineering, Information Systems (IS), and Manufacturing functions.
• Provide testing and IT compliance guidance, and timely response and follow-through in the resolution of IT compliance issues.
• Execute quality oversight directly in Quality systems.

• Bachelor's degree in engineering, Biochemistry, Biology, Chemistry, or related science field.
• Demonstrated ability to perform or provide oversight of GMP operations including following detailed SOPs, maintaining training, data integrity principles, and good documentation practices.
• Experience managing projects through completion while meeting timelines.
• Experience evaluating documentation and operations according to company procedures and related regulations.
• Experience working with Quality Systems.
• Strong organizational skills and ability to manage multiple tasks at one time.
• Effective communication skills (both written and verbal).
• Demonstrated ability to work as both a team player and independently.
• Solid understanding and application of aseptic behaviors and principles.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.