Quality Specialist

Quality SpecialistBe the champion of quality! Be hands-on, catch issues before they become problems, keep production on track, and ensure every batch is safe, compliant, and Right First Time. Coach the team, drive improvements, and make a real impact every day!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 day - Move, Traverse: 3/4 of the day and up - Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up - Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day - Ascend/Descend or Work Atop: From 1/4 to 1/2 of the day - Position self (to) or Move (about or to): 3/4 of the day and up - Communicate or exchange information: 3/4 of the day and up - Detect, distinguish, or determine: 3/4 of the day and up - On an average day, the individual can expect to move and/or transport up to 25 pounds less than 1/4 of the day - This position may have the following special vision requirements: Close Vision, Distance Vision, Color Vision, Peripheral Vision, Depth Perception, Ability to focus - Work 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 day - Work is primarily performed at a desk and/or in an office environment. for up to 1/4 of the day - Work near moving mechanical parts for 3/4 of the day and up - Fumes or airborne particles for up to 1/4 of the day - The noise level in the work environment is typically moderate - Ability to work overtime and/or weekend work - Attendance to work is an essential function of this position