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Quality Engineer at My Equinox Consultancy LLC / America Jobs
This job ad has been posted over 40 days ago...


Full-time Quality Engineer

at My Equinox Consultancy LLC in Maine

Line QE’s Co-located with Production
Line QEs are an independent Quality resource partnered with Production Supervision / Team Leads to facilitate GMP, GDP, and Company standard compliance. We work as a team to achieve the overall site goal for on time delivery of high-quality product.
• Line QE’s who are co-located with Production will have a workspace in their assigned work area allowing for a constant presence in the area.
o An area on 2nd floor will be available for storage of personal items, laptops (if left on site during off hours) and for breaks / lunches.
• Perform lot change line clearance activities according to batch record
• Perform shift change activities according to batch record
• Perform set-up verification activities according to batch record
• Perform Label Verification according to SMO/batch record
• Observe daily Production activities to ensure activities are being completed in compliance with documented procedures.
• Coach operators on correct Production processes and when necessary correct operator actions in conjunction with Team Lead / Supervisor
• Perform In Process Quality Checks to verify product is being manufactured to expected quality level i.e., no missing parts, correct lot #s, proper part placement.
• When quality issues are identified LQE’s will supervise / facilitate bracketing and containment activities
• Verify operators have been trained to perform RP instructions and observe RP activities to ensure they are executed in compliance with instructions.
• Escalate any quality issues and discrepancies to Sr. QE / Team Lead
• Continually review batch records as the build occurs. Coach and have operators correct mistakes when identified.
• Coach personnel filling out batch records on Good Documentation Practices. Use BRFT data to address GDP gaps.
• Maintain assigned Production area procedure binder. This requires identification of all procedures that apply to the functions in that area and printing them every 48 hours, or as documents / Deviations are released, to maintain compliance with document control requirements. Remove expired Deviations and obsolete versions of procedures from point of use.
• Perform a complete BR review before being sent to QA for release. This is most efficiently done in combination with the Supervisor, however if they are not available use flags to identify any errors that need to be fixed and follow up with the Supervisor to have Production personnel make corrections before being sent to next department.
• Assist with production personnel training
• Ensure In Process i.e., leak test, QC samples are collected.
• Verify challenge and event-based testing has been completed according to BR requirements.
• Perform GMP walks in assigned area and at the identified frequency.
• Work with assigned area to implement corrections that result from QI / CAPA solutions or GMP walk observations
• Attend Tier 1 meetings
• Send shift pass down information to Sr. QE / Team Lead before the end of each shift.
Reference : Quality Engineer jobs

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Published at 19-07-2022
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