Laboratory Equipment Specialist II

Kindeva • Bridgeton, MO

1d • Onsite

About The Position

The QC Specialist-Lab Equipment manages the Quality Control Chemistry laboratories’ equipment maintenance program. The role performs calibration and preventive maintenance (PM) of laboratory equipment, including unscheduled maintenance and service, and conducts out-of-tolerance and laboratory investigations. It also conducts periodic reviews and provides or coordinates training on laboratory equipment and related system software applications.

Working under general supervision and using established policies and procedures, the incumbent contributes to team objectives and project milestones. The role supports continuous improvement and regulatory audit readiness, serves as a system administrator for standalone laboratory computer applications, and ensures laboratory equipment is appropriately calibrated and maintained. The specialist determines when equipment requires recalibration; provides technical support for selection and evaluation of new equipment; implements action items from trending, Kindeva Quality Standards, and Compliance Analysis Status reports; and evaluates changes to validated or qualified laboratory equipment and facilities.

The role approves new or modified calibration and PM acceptance criteria that may affect product safety, identity, strength, or quality, including validation and regulatory commitments. Additional work includes authoring and supporting SOP revisions and change control requests; reviewing validation and qualification protocols, technical reports, project plans, trend reports, equipment calibration and PM records, and procedures; and performing other duties within the quality department as required.

Requirements

• Bachelor of Science in Chemistry.
• At least 5 years of experience in pharmaceutical laboratory operations and laboratory equipment maintenance.
• Knowledge of 21 CFR 210/211.
• Understanding of the working principles of common, simple, and complex laboratory equipment.
• Familiarity with special analytical techniques and procedures for laboratory operations and calibration/PM programs.
• Excellent analytical and investigation skills.
• Experience with the Empower Chromatographic Data System and instrument-specific software applications.
• Fluent spoken and written English.

Nice To Haves

• Experience in laboratory equipment operation, calibration, preventive maintenance, and leadership.
• Good planning, oral, written, and interpersonal communication skills.
• Basic computer literacy.
• Ability to organize time independently and prioritize workload.
• Expertise in analytical laboratory techniques, laboratory equipment operation/calibration/PM, compendial requirements, chromatography, Empower, and technical writing.
• Experience using Lean, Six Sigma, or other continuous improvement methodologies for process improvement.

Responsibilities

• Perform equipment calibration, verification, and preventive maintenance according to established procedures.
• Review calibration, verification, and PM data to ensure equipment is serviced according to predetermined schedules and procedures.
• Maintain calibration and PM records, including standards certificates and calibration due lists.
• Maintain calibration standards or test equipment needed to support the program.
• Maintain records of calibration or PM service contractors and approve contractor procedures.
• Ensure laboratory equipment procedures align with applicable compendial and regulatory requirements, such as USP/NF and EP.
• Notify equipment owners and Quality Assurance of discrepancies found during maintenance or calibration.
• Maintain the Laboratory Equipment Master List in an inspection-ready state.
• Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, and recommend appropriate corrective actions.
• Apply existing techniques and procedures, recommend improvements, and implement modifications to improve laboratory efficiency and productivity.
• Coordinate and support laboratory equipment training.
• Serve as system administrator for standalone laboratory computer applications.
• Determine when equipment requires recalibration and provide technical support for the selection and evaluation of new equipment.
• Implement action items arising from trending, Kindeva Quality Standards, and Compliance Analysis Status reports.
• Evaluate changes to validated or qualified laboratory equipment and laboratory facilities.
• Approve new or modified calibration and PM acceptance criteria that may affect product safety, identity, strength, or quality.
• Author and support SOP revisions and change control requests; review validation and qualification protocols, technical reports, project plans, trend reports, equipment calibration and PM records, and procedures.
• Perform other duties within the quality department as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level