Quality Assurance specialist (QMS)

Main Functions an****************
The Quality Assurance Specialist will report directly to the localBioReliance Validation Services (BVS) Quality Manager an******** workdirectly with other BVS Quality Assurance Chemi********, validationproject coor******** laboratory management, an******** Global TechnicalSupport (GTS) SME.
Primary responsibilities are reviewing Physical an******** protocolsan********, laboratory records an******** data as well as identifyingopportunities for an******** implementation of continuous improvement asdirecte******** the BVS Quality Manager and/or Global Hea********Quality for BVS. Additional responsibilities include issuance an********of test workshee******** recor******** conducting self-inspectionsan******** au******** supporting the maintenance an******** activitiesrelate******** the laboratory’s Quality Systems as directe******** theBVS Quality Manager including but not limite******** supporting theclosure of data integrity gaps, performing routine inspection oflaboratory records to ensure audit rea******** handling ******** CAPAan******** controls assignments an******** instrumen********qualification protocols an********. The position’s main responsibilities include:
• Quality Reviewer for Test Protocols an********
* Bubble Point Testing
* Preservative Binding Studies
* Diffusion ratio an******** Determination
* Compatibility Testing
* Compatibility Certification
* Environmental an******** Monitoring records.
* Bacterial retention study as needed
• Worksheet issuance -Worksheet issuance for all the study.
• Document controller(Creation an******** of SOP’s when required.Periodic Effectiveness of Validity revie********)
• Deviations an********( (process an******** for non-conformance, OOS,etc. in Trackwise).
• Managing/Maintaining Supplier Quality Management Program.
• Review of cal******** PM an******** reports, Environmental an********Monitoring records.
• Validation Master Plan execution as need.
• Manually recor******** when neede******** to the learning plans.Periodically run training completeness as need.
• Monthly review of Lab logs.
• QMS improvement an******** closure.
• Monthly Sample Discar******** verification.
• GAGE Trak Usage for calibration program.
• Lea******** Failure Investigations(RCA practice) - give test failureinvestigations highest priority due to potential impac******** to thebus******** customers an********, use improve******** workflo********
• Supporting to Customer Au******** ISO au******** self-inspection audits
• Oversee execution to schedule to ensure equipment ******** softwarean******** are

qualified/available for use an******** for purpose.
• Visual management – KPI/KQI/Metrics (balance scorecards) providing data.
• Monthly barometer inpu********
• Actively demonstrate Merck values & behaviors.
• GAGEtrak Usage for calibration program.
• In collaboration with worldwide BioReliance Lab Quality lea********actively participate in the g