Abacus
Sr. Metrology Specialist
Abacus, Morris Plains, NJ, United States
Description:
General Shift
Business Title: Sr. Metrology Specialist
Job Title: Sr. Metrology Specialist
Department: Facilities and Engineering
Reports to : Metrology Supervisor
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.
Hours per Day 7.5 Hours per Week 37.5 Total Hours 1,905.00
General Shift
Business Title: Sr. Metrology Specialist
Job Title: Sr. Metrology Specialist
Department: Facilities and Engineering
Reports to : Metrology Supervisor
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.
Hours per Day 7.5 Hours per Week 37.5 Total Hours 1,905.00