QA Calibration Specialist

QA Calibration Specialist

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients' needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices.

We at Eliquent are looking for a QA Calibration Specialist to immediately join our Eliquent Consulting: Columbus team. The QA Calibration Specialist is a FTE project-based role. 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—from URS and design through commissioning, qualification, and operational handover. This role drives calibration quality oversight, authoring/approving documentation, and partnering with Engineering, Metrology, Validation, and Operations.

Description:

• 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.

Qualifications and Requirements:

• 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:

What We Offer:

Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.

Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.

Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.