Quality Lead - Validation + Metrology (GMP)
This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$48.75/hr - $56.25/hr
Healthcare benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, financial protection benefits, as well as HSA, FSA, and DCFSA account options. 401k retirement account access is offered starting on the 90th day with employer matching after one year of service. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
Hours: 9am-5pm Monday - Friday
Requirements:
- Degree in a Science / Engineering related field required, with preferred focus or experience in pharmaceutical manufacturing
- Minimum 5 years' experience in pharmaceutical manufacturing environment
- Strong experience within metrology, validation, and calibration of pharmaceutical manufacturing equipment
- Hands on experience, or exposure to the implementation of a metrology/validation program
- Experience working with CMO, CDMO, or start up environments.
Preferred:
- Experience with Blue Mountain software
- Experience with equipment logbooks
- Experience within Cell & Gene therapy programs
Day to Day:
One our large pharmaceutical clients is looking to hire a Quality Lead to help build out a metrology program from the ground up and drive implementation of a tool (Blue Mountain software) for tracking, scheduling, and documenting the calibration activities and inventory. This individual will be supporting an external contract manufacturing organization producing a Phase Ib clinical CAR-T program.
Main responsibilities will include:
- Setup calibration, testing, repair, inspection, and maintenance of equipment
- Schedule, manage, host calibration and validation vendors
- Responsible for asset management
- Helping with onboarding and relocating system
- Tagging of systems
- Responsible for calibration/pm
- Oversee work by outside contractors to ensure compliance
- Coordination with system owners
- Reviews results and document from vendor performed calibrations
- Recommends and initiates activities to ensure area and equipment are maintained in a state of compliance
- Initiates and documents calibration deviations and out of tolerance events
- SME for calibration activities
- Performs equipment troubleshooting and repair
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Engineering, Quality Assurance, and Science
Industries
- Pharmaceutical Manufacturing and Biotechnology Research