Metrologist

Job Description

SUMMARY OF FUNCTIONS:

Assure that all laboratory equipment is maintained properly in accordance with cGMPs, SOPs, industry guidelines/expectations and manufacturer’s requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Manages instrument and equipment calibration, preventative maintenance and qualification programs.  Ensures compliance to cGMPs, SOPs, industry expectations and manufacturer’s requirements.
  • Coordinates and manages vendor activities ensuring compliance to internal SOPs, industry standards and manufacturer requirements.  Reviews documentation and work performed (protocols, reports, test records/scripts, certificates, etc.) for accuracy and cGMP compliance.
  • Maintains current electronic calibration/PM tracking software and environmental chambers monitoring software.
  • Creates and modifies necessary SOPs.  Aids laboratory operations in the creation or modification of operational SOPs.
  • Performs investigations into calibration/PM/Qualification related deviations.  Determines appropriate root causes and implements necessary Preventative and Corrective Actions.
  • Performs gap analysis and risk assessment on new and existing instrumentation/equipment with respect to manufacturer’s requirements and current industry requirements.  Aids in development of remediation plan and performs assigned tasks.
  • Works with engineering, quality, and laboratory personnel in evaluation of new instrument/equipment needs and selection.
  • Considered instrument/equipment SME with respect to calibrations, preventative maintenance and qualification requirements.  Supports client and regulatory audits.
  • Creates necessary Training programs and performs necessary Training.
  • Prepares and maintains required records and quality related documentation.

Job Requirements

ORGANIZATIONAL RELATIONSHIPS:

Reports to the Director, Quality Assurance.

EDUCATIONAL OR SKILL REQUIREMENTS:

Four year degree in Chemistry, Engineering or related scientific field.

Three to five years of relevant experience in a FDA regulated work environment including responsibilities related to calibration, preventative maintenance and qualification of instruments/equipment.

Competencies include: planning and organizational skills, problem analysis, judgment, team work. Computer skills especially related to Microsoft Office and typical Quality system software.  Detail oriented and a clear understanding of cGMP requirements.

All interested applicants must apply online.  AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness.  Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.

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2019-01-30T19:58:38+00:00