Quality Specialist

Quality SpecialistHelp ensure the quality, safety, and integrity of life-changing medications. We're looking for a Quality Auditor in Rockford, IL to provide hands-on production floor support, verify cGMP compliance, audit manufacturing processes, and drive continuous improvement. This role is ideal for someone who enjoys solving problems, collaborating with operations, and making a measurable impact in a highly regulated pharmaceutical manufacturing environment.Quality Specialist Responsibilities include but are not limited to:Perform production room approvals after product and lot changesVerify first piece inspection to ensure finished goods code, format, and expiration date are correctEnsure equipment is packaged within validated parameters and equipment calibration dates on all process equipment are within required specifications. If not, this individual will contact the appropriate personnel to recalibrate and/or remediate the issueReview batch record to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately. Conduct periodic checks to confirm hourly inspections are being performed correctly and on track to meet requirementsReview sampling pages to ensure samples have been taken, labeled and documented appropriatelyAudit production room to ensure Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks have been completed accurately and timelyConfirm package (unit) functionality (perfs, peel, push, seals, etc.)Check to ensure portable equipment has been cleaned and documented correctly on quality formAudit production personnel to ensure the job is performed safely including wearing required personal protective equipmentEnsure recovery stations are segregated from product flowConfirm bulk material and components for job are correct and kept coveredReview each equipment clean room logbooks for correct clean room, entries are complete, correct and legibleReview temperature and humidity data to ensure within acceptable job parametersDocument audits using the Quality Auditor checklist listing the room, production job description, and date when the audit was conductedIdentify proactively gaps in batch records and to mitigate deviations and documentation errorsParticipate on improvement teams (i.e. FMEA's, Kaizen, batch record etc.) as neededSupport Root Cause Analysis as neededEnsure 5s (Sort, Set in order, Shine, Standardize, Sustain method) ComplianceAdhere to cGMP (Current Good Manufacturing Practices), and GCP (Good Clinical Practices) policies, procedures, rulesQuality Specialist Requirements:Stationary Position: Under a 1/4 of the dayMove, Traverse: 3/4 of the day and upOperate, activate, use, prepare, inspect, or place: 3/4 of the day and upInstall, place, adjust, apply, measure, use, or signal: Up to 1/4 of the dayAscend/Descend or Work Atop: From 1/4 to 1/2 of the dayPosition self (to) or Move (about or to): 3/4 of the day and upCommunicate or exchange information: 3/4 of the day and upDetect, distinguish, or determine: 3/4 of the day and upOn an average day, the individual can expect to move and/or transport up to 25 pounds less than 1/4 of the dayThis position may have the following special vision requirements: Close Vision, Distance Vision, Color Vision, Peripheral Vision, Depth Perception, Ability to focusWork is performed in areas with moderate risk or discomfort that may require special safety precautions, such as -wearing protective clothing or gear for up to 1/4 of the dayWork is primarily performed at a desk and/or in an office environment. for up to 1/4 of the dayWork near moving mechanical parts for 3/4 of the day and upFumes or airborne particles for up to 1/4 of the dayThe noise level in the work environment is typically moderateAbility to work overtime and/or weekend workAttendance to work is an essential function of this positionAbout us: QPS Employment Group is a full-service staffing firm comprised of dedicated and passionate people with over 50 offices throughout the United States. We place great people with great companies in industrial, skilled trades, administrative, manufacturing, general labor and professional employment. Hiring immediately! Why Work with QPS? - Access to sought-after positions with leading employers - Dedicated placement specialists who will guide you through every step of the job search process Best of all, our job matching and resume assistance services are 100% free to job seekers and we will never ask you to pay a fee! We are proud to be an equal opportunity employer.