LanceSoft
Job Title: Sr. Metrology Specialist
Location: Morris Plains, NJ 07950
Duration: 12 months
Job Purpose:
Responsible for a variety of tasks related to laboratory and manufacturing instrumentation, as managing and overlooking equipment. Supporting change requests and completing in a timely manner. Support the equipment enrollment process for life cycle documentation of equipment, TR&D, and MS&T equipment. Contacts vendors, when needed, and coordinates their activities.
Major Accountabilities:
Responsible for effective and efficient calibration to ensuring compliance with Client quality standards and applicable CGMP regulations.
Support Lead with maintaining the calibration schedule for all equipment and instruments on site.
Facilitates instrumentation calibration/qualification with external vendors, internal and/or external resources and local system owners
Ensure compliance to cGMP, regulatory regulations and Client global and local policy for equipment
Assistance field execution of various protocols, prepares summary reports, co-ordinates report review and approvals with various Users and QA Compliance
Develop / review appropriate SOPs and corresponding Forms
Responsible for performing all assigned activities within budget and schedule constraints
Ensure effective communication flow with all departments.
As subject matter expert. provide support during audit and inspections
Maintain calibration of all manufacturing and QC equipment
Key Performance Indicators:
Conformance to the equipment utilization KPI's.
On Time Calibrations (no over dues)
Ideal Background:
Education:
High School degree required.
BS/BA degree in Engineering or the life sciences or other related field is preferred not required.
Languages:
Fluent in speaking / writing in English
Experience:
4-5 years of Pharmaceutical industry experience required.
Minimum of 3 years of calibration experience or applicable experience in a related area.