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Clark & Enersen · 1 month ago

QA Calibration Specialist

Columbus, OH, US

Full-time

Hybrid

Mid, Senior Level

$90K/yr - $110K/yr

2+ years exp

Clark & Enersen is a leading global consulting firm in life sciences, and they are seeking a QA Calibration Specialist to join their Columbus team. This role involves ensuring measurement systems are qualified, calibrated, and compliant throughout the project lifecycle, as well as driving calibration quality oversight and collaborating with various departments.

Consulting

Responsibilities

Provide QA oversight for calibration and metrology activities within the capital expansion: design review, URS, risk assessments, IQ/OQ/PQ, and turnover

Review/approve calibration-related URS, design deliverables (P&IDs, I/O lists, instrument indices), data sheets, and vendor documentation

Ensure instruments are specified with appropriate accuracy, range, environmental ratings, and materials of construction; challenge acceptance criteria and tolerances using risk-based rationale

Participate in punchlist/walkdowns; verify instrument tagging, labeling, and accessibility; ensure as-built consistency

Stand up/expand the site calibration program for new assets: master instrument list, criticality ranking, and calibration intervals using risk-based methodology (e.g., impact/criticality to product quality and patient safety)

Author/review SOPs, calibrations methods, MSA/gage R&R where applicable, and templates for certificates and Out-Of-Tolerance (OOT) investigations

Configure and maintain the CMMS (e.g. Blue Mountain) item masters, routes, tasks, and change controls; ensure NIST/traceable standards and vendor ISO/IEC 17025 accreditation are in place

Define spare/standard strategy (transfer standards, environmental references, field kits) and quarantine/lockout for failed instruments

QA review/approval of calibration plans, certification plans, certificates, data sheets, and logical test scripts; verify uncertainty, as-found/as-left, environmental conditions, and traceability are documented

Triage and lead quality investigations for OOT and drift trends; implement CAPAs, deviation containment, and effectiveness checks

Ensure data integrity (ALCOA+) in paper and electronic records; partner with CVS for instrument/lab equipment with software components and data acquisition

Contribute to PQ readiness: verify critical instruments are released, tagged, and loaded into the CMMS with due intervals prior to process validation

Partner with Engineering, CQV, Manufacturing, Facilities/Utilities, and QC to align calibration with commissioning schedules and startup milestones

Support vendor management: technical assessments, quality agreements for calibration labs and service providers, and periodic performance reviews

Provide training and coaching to technicians and end-users on calibration expectations and GDP

Qualification

GMP calibrationMetrologyTechnical writingCMMS familiarityRisk-based decision makingPlanningPrioritizationCollaborative influenceRoot cause analysisAttention to detail