Quality Specialist

Job Description

Position Title: Quality Specialist

Wage: $16.20 - $20.15/hour

Shift: 1st, 2nd or 3rd or 12 Hour Weekend Nights

Hours: 7:00am - 3:00pm (Monday
- Friday), 3:00pm - 11:00pm (Monday
- Friday), 9:00pm - 7:00am (Monday
- Thursday) or 7:00pm - 7:00am (Friday
- Sunday)

Help 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.

• Perform production room approvals after product and lot changes
• Verify first piece inspection to ensure finished goods code, format, and expiration date are correct
• Ensure 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 issue
• Review 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 requirements
• Review sampling pages to ensure samples have been taken, labeled and documented appropriately
• Audit production room to ensure Cleaning and Use logbooks, Mechanical Set‑up logbooks, and Preventive Maintenance logbooks have been completed accurately and timely
• Confirm package (unit) functionality (perfs, peel, push, seals, etc.)
• Check to ensure portable equipment has been cleaned and documented correctly on quality form
• Audit production personnel to ensure the job is performed safely including wearing required personal protective equipment
• Ensure recovery stations are segregated from product flow
• Confirm bulk material and components for job are correct and kept covered
• Review each equipment clean room logbooks for correct clean room, entries are complete, correct and legible
• Review temperature and humidity data to ensure within acceptable job parameters
• Document audits using the Quality Auditor checklist listing the room, production job description, and date when the audit was conducted
• Identify proactively gaps in batch records and to mitigate deviations and documentation errors
• Participate on improvement teams (i.e. FMEA's, Kaizen, batch record etc.) as needed
• Support Root Cause Analysis as needed
• Ensure 5s (Sort, Set in order, Shine, Standardize, Sustain method) Compliance
• Adhere to cGMP (Current Good Manufacturing Practices), and GCP (Good Clinical Practices) policies, procedures, rules

• 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 at work is an essential function of this position

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We are proud to be an equal opportunity employer.