Laboratory Equipment Specialist II
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, conducts out-of-tolerance and laboratory investigations, and conducts periodic reviews and provides or coordinates training on laboratory equipment and related system software applications. Working under general supervision and following established procedures, the specialist contributes to team objectives and assigned project milestones while driving continuous improvement and maintaining regulatory audit readiness. The role also serves as a system administrator for standalone laboratory computer applications, supports equipment selection and evaluation, evaluates changes to validated or qualified equipment and laboratory facilities, and approves new or modified calibration/PM acceptance criteria that may affect product safety, identity, strength, or quality. Additional work includes authoring and supporting SOP revisions and change-control requests, and reviewing validation and qualification protocols, technical reports, project plans, trend reports, equipment procedures, and calibration/PM documentation.
Requirements
- Bachelor of Science in Chemistry.
- At least 5 years of previous 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 ability to understand and implement procedures for laboratory operations and calibration/PM programs.
- Excellent analytical and investigation skills.
- Experience with Empower Chromatographic Data System and instrument-specific software applications.
- Fluent in spoken and written English.
Nice To Haves
- Experience in laboratory equipment operation, calibration, preventive maintenance, and leadership.
- Good planning, oral communication, written communication, and interpersonal skills.
- Basic computer literacy and ability to organize time independently and prioritize workload.
- Expertise in analytical laboratory techniques, laboratory equipment operations/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 maintained according to predetermined schedules and procedures.
- Maintain calibration and PM records, including standards certificates and calibration due lists.
- Maintain calibration standards or test equipment supporting the program.
- Maintain records for calibration or PM service contractors and approve contractor procedures.
- Ensure laboratory equipment procedures align with applicable compendial requirements, including 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 corrective actions.
- Apply existing techniques and procedures, recommend improvements, and implement modifications to improve laboratory efficiency and productivity.
- Coordinate and support laboratory equipment training.
- Conduct out-of-tolerance and laboratory investigations and periodic reviews.
- Serve as system administrator for standalone laboratory computer applications.
- Provide technical support for selecting and evaluating 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/PM acceptance criteria that may affect product safety, identity, strength, or quality, including validation or regulatory commitments.
- Author and support SOP revisions and change-control requests; review validation/qualification protocols, technical reports, project plans, trend reports, and equipment calibration/PM procedures.
- Perform other duties within the quality department as required.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
