ELIQUENT Life Sciences · 8 hours ago
QA Calibration Specialist
Columbus, OH
Part-time
Onsite
Mid, Senior Level
$90K/yr - $110K/yr
2+ years expELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies. The QA Calibration Specialist is responsible for ensuring measurement systems used in production, utilities, facilities, and QC labs are qualified, calibrated, and compliant throughout the project lifecycle.
ConsultingMedical DeviceProfessional Services
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
Examples of potential Systems and Asset Scope: Utilities/Facilities - WFI/PW, clean steam, compressed gases, HVAC/BMS/EMS, autoclaves, cleanrooms, differential pressure, temperature, humidity, flow, level, pressure, and control valves. Process Equipment - formulation/skids, vial/bag filling, lyophilizers, CIP/SIP, mixing and transfer systems, packaging. QC/Analytical - balances, pipettes, HPLC/UPLC, GC, spectrophotometers, TOC, conductivity, osmometers, pH/DO, environmental monitoring
Qualification
Required
Bachelor's degree in Engineering, Metrology, Life Sciences, or related field; or equivalent relevant experience
2+ years (Associate) / 5+ years (Specialist) experience in GMP calibration, metrology, or QA oversight in pharma/biotech or medical device
Hands-on familiarity with CMMS, risk-based calibration, and OOT/CAPA investigations
Strong technical writing, attention to detail, and ability to read P&IDs, wiring diagrams, and instrumentation data sheets
Risk-based decision making and critical thinking
Planning and prioritization in a fast-paced project environment
GMP documentation excellence and data integrity mindset
Collaborative influence and vendor management
Root cause analysis and continuous improvement
Benefits
Health, dental, vision, and life insurance
401(k) plan with employer match
Generous paid time off policy
Additional perks
Company
ELIQUENT Life Sciences
ELIQUENT Life Sciences is a regulatory consulting firm for the life sciences industry.
501-1000 employees
H1B Sponsorship
ELIQUENT Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (29)
2024 (3)
Funding
Current Stage
Late StageLeadership Team
Stephen Purtell
Chief Financial Officer
Rob Wojciechowski
Chief Operating Officer
Recent News
2025-05-08
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2025-04-07
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