The Metrology Specialist is responsible for a variety tasks related to calibrations of equipment, managing and overlooking equipment change requests in a timely manner. Contacts vendors, when needed, and coordinates their activities.
Responsible for effective and efficient calibration to ensuring compliance with Novartis quality standards and applicable CGMP regulations.
Facilitates instrumentation calibration/qualification with external vendors, internal and/or external resources and local system owners.
Supports the preparation of equipment binders containing technical & qualification Novartis life cycle documents & required vendor documents, IQ/OQ/PQ Protocols, and Summary Reports for qualification of QC equipment.
Ensure compliance to cGMP, regulatory regulations and Novartis global and local policy for equipment.
Develop / review appropriate SOPs and corresponding Forms.
Responsible for performing all assigned activities within budget and schedule constraints.
Ensure communication flow in the Analytical Service team and with all individuals involved in the process (e.g. Value Stream (Make- Test- Release) team.
As subject matter expert provide support during audit and inspections.
High School degree required; BS/BA degree in Engineering or the life sciences or other related field is preferred.
3+ years of relevant experience is required.
Relevant calibration experience, or applicable experience in a related area, is required.
Previous GMP experience is required.
Previous experience in pharmaceutical industry.
Comprehensive benefits package including health, life and disability benefits.
401(k) with company contribution and match.
Generous time off package including vacation, personal days, holidays and other leaves.