Job Description:

Responsibilities will include (but not limited to):

• Qualify QC equipment.

• Design, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ protocols, software test scripts, risk assessments, qualification summary reports.

• Own change controls specific to the qualification of QC instruments and its associated software.

• Update the asset management database to reflect new assets, calibrations, preventative maintenances.

• Author instrument operational SOPs as needed.

• Assist with onboarding/relocating instruments.

• Decommission equipment as needed.

• Coordinate/interface/host vendors on site.

• Champions qualification deviations, identifying root causes and Corrective Actions/Preventive Actions (CA/PAs).

• Acts as the liaison between Digital Plant (IT) and lab departments.

Qualifications and Experience Required:

• Bachelor’s degree in relevant scientific, engineering, or computer-based area with a minimum of 4 years experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience.

• Quality management system experience that includes document control/management, change controls, investigations, deviations, asset management database.

• Knowledge of cGMP regulatory requirements, Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects.

• Demonstrated success in cross functional influencing, strong communication, and collaboration skills

• Must have equipment validation experience.

• Must have GMP experience.

• Must have change control experience.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.