Onsite Quality Coordinator
Job SummaryThis role will require onsite presence at our facility in the Detroit metro area.The Quality Coordinator must ensure the integrity and compliance of assigned elements of the Dialog Direct Quality Operating System (QOS). Such assigned elements include responsibility for the day-to-day operation of one or more of the following:
Internal Audits - both Operational and Client requirementsDocument ControlCorrective ActionPharmaceutical Batch Record Review/ApprovalThe role provides support to the Director of Quality for Marketing Services and will also be the face of the organization with interacting with our customers' Quality teams.
Job Description:
Conduct Quality Audits of departments, processes, and records according to ISO 9001:
2015 standards, GMP regulations, and specific customer requirements as appropriate. Identifies and reports quality deficiencies.Document ControlContribute to maintaining SharePoint Document Control.Corrective ActionsMonitor SharePoint and assign Corrective Actions to appropriate staff member.Perform verification of completed actions to resolve issues, as assigned.Facilitate pharmaceutical or lot/exp Batch Record Documentation, including submission to Client QA managers, where applicable.Review and approve batch documentation provided by Production.Complete reconciliation forms and Certificate of Compliance (COC) or Certificate of Analysis (COA).Maintain tracking tools (spreadsheets/SharePoint).Inspections, as required, for new kit builds, providing feedback to client.Participate in other Quality-focused initiatives, as assigned.Voluntary Self-Identification of Disability FormArea of expertise (Skills)KNOWLEDGE, SKILLS, AND ABILITIES:
Previous experience in Quality-related initiatives; TQM, cGMP regulations, or ISO certification is desired.Excellent communication skills.Previous auditing and training background.Ability to develop and maintain written procedures.Proficient with Microsoft Office Suite (Excel, Word, PowerPoint, Visio), and SharePoint.Lean Six Sigma familiarity/certification is preferred but not required.EDUCATION:
BA or proven record of experience with Quality-related initiatives. Recommended Skills Auditing Certified Global Meeting Planner Communication Iso 9000 Lean Six Sigma Microsoft Excel Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3m5986s7hqx3g1jbcb', 'ExternalApply-j3m5986s7hqx3g1jbcb'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
n
n
n Estimated Salary: $20 to $28 per hour based on qualifications.
Internal Audits - both Operational and Client requirementsDocument ControlCorrective ActionPharmaceutical Batch Record Review/ApprovalThe role provides support to the Director of Quality for Marketing Services and will also be the face of the organization with interacting with our customers' Quality teams.
Job Description:
Conduct Quality Audits of departments, processes, and records according to ISO 9001:
2015 standards, GMP regulations, and specific customer requirements as appropriate. Identifies and reports quality deficiencies.Document ControlContribute to maintaining SharePoint Document Control.Corrective ActionsMonitor SharePoint and assign Corrective Actions to appropriate staff member.Perform verification of completed actions to resolve issues, as assigned.Facilitate pharmaceutical or lot/exp Batch Record Documentation, including submission to Client QA managers, where applicable.Review and approve batch documentation provided by Production.Complete reconciliation forms and Certificate of Compliance (COC) or Certificate of Analysis (COA).Maintain tracking tools (spreadsheets/SharePoint).Inspections, as required, for new kit builds, providing feedback to client.Participate in other Quality-focused initiatives, as assigned.Voluntary Self-Identification of Disability FormArea of expertise (Skills)KNOWLEDGE, SKILLS, AND ABILITIES:
Previous experience in Quality-related initiatives; TQM, cGMP regulations, or ISO certification is desired.Excellent communication skills.Previous auditing and training background.Ability to develop and maintain written procedures.Proficient with Microsoft Office Suite (Excel, Word, PowerPoint, Visio), and SharePoint.Lean Six Sigma familiarity/certification is preferred but not required.EDUCATION:
BA or proven record of experience with Quality-related initiatives. Recommended Skills Auditing Certified Global Meeting Planner Communication Iso 9000 Lean Six Sigma Microsoft Excel Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3m5986s7hqx3g1jbcb', 'ExternalApply-j3m5986s7hqx3g1jbcb'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
n
n
n Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
