Quality Control Senior Associate

Note:
This position will be one of the following: remote or hybrid role (3 days onsite/week)
Work Schedule: Dayshift


This position will, under BPO supervision, execute deliverables for a project to implement ***'s new, fully Electronic Lab Notebook (ELN) system. This is a non-laboratory testing position.


This position will be responsible for performing activities towards the design, configuration, and validation of the new ELN system, recreation and/or migration of required master data, and involvement in deployment of production instances at the site(s).


This position will be expected to adhere to established procedures (Standard Operating Procedure, Work Instruction) for safety and cGMP/CFR requirements which includes, but is not limited to, expectations of training and documentation practices.


This position will work in a team environment, collaborating with various colleagues in the *** network to ensure project commitments are met. They will report status/updates of key responsibilities and escalate any issues through the project management team.
Key Responsibilities for the new ELN system:
• Participate in process engineering activities
• Facilitate the development of new business SOPs, Forms, Manuals, etc. using new processes/workflows
• Participate in system requirement, software configuration, and design activities
• Receive and/or verify master data for the site(s)
• Coordinate ELN Template development and review with site SMEs
• Support the development and review of Operational Qualifications
• Execute User Acceptance Testing & Data Migration Verification
• Review and provide input on training materials
• Support training material development by providing inputs and reviews
• Support site Instrument Qualification activities such as planning and execution
Basic Qualifications

Bachelor's degree and 2 years of industry Quality Control or Quality experience
OR
Associate's degree and 6 years of industry Quality Control or Quality experience
OR
High school diploma / GED and 8 years of industry Quality Control or Quality experience