Job Description


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


  • 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


Reports to the Director, Quality Assurance.


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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