- Expiry Date: 12 February 2023
- Referral: email@example.com
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.