QC Associate II, Equipment Management (Contract)

The QC Associate will support the QC laboratory at our client’s facility in Waltham. In this role, you will be primarily responsible for managing the lifecycle of QC instruments used in support of client’s vector, gene and cell therapy programs.

Functions:

• Collaborate with all QC functions (i.e. QC Microbiology, QC Raw Materials, QC Analytics, and QC Outsourcing/Logistics) and Analytical Development to onboard QC instruments and ensure that validation is appropriate given the use of the system.
• As the QC system owner, collaborate with Validation Engineering, IT, Metrology, and QA Validation to author or review and approve IOQ/validation packages, including IA, URS, and associated validation plan/report.
• Draft and/or revise operational SOPs.
• Review OOTs identified following calibration and initiate deviations as appropriate.
• Oversee equipment/instrument maintenance, PM, and calibration, in collaboration with asset owner, facilities, and metrology.

Requirements

Requirements:

• Bachelor’s degree in a technical discipline (Biology/Molecular Biology/Chemistry/Engineering) with a minimum of 1-5 years of experience, preferably in a GMP QC laboratory setting.
• Experience with the validation process for QC instruments.
• Excellent organizational skills and attention to detail.
• Ability to work independently and communicate/collaborate with scientific/technical personnel.
• Experience performing investigations for deviations.
• Knowledge of GMPs, SOPs, and Quality System processes.  
• Experience working with electronic systems (Kneat, CMMS, LIMS, QMS) is a plus.