Quality Assurance Compliance Associate III

Company: Rentschler Biopharma, Inc.
Location: Milford
Posted on: January 24, 2023

Job Description:

Job SummaryThe Quality Assurance Compliance Associate III is responsible for all activities related to compliance process. This individual is responsible to support client facing deliverables, customer communications and assist in regulatory commitments. Coordinate efforts globally for harmonization of inspection readiness compliance for the site.Key ResponsibilitiesProvide Quality and Regulatory support for clients for authority / agency inspections and auditsInspection Readiness Activities for current and new health authority (PAI) inspections Internal Audit program and regulatory inspectionsSupport client audits and regulatory authority inspections with Subject Matter Experts and key stakeholders.Interface with Audit team and represent the company during AuditsWork cross site with Global Regulatory team to ensure authority deliverables are met to maintain complianceProvide inspection support for the timely delivery of documents, provide coaching for subject matter experts for inspection readiness, and review information into the inspection's rooms for complianceSupport Audit responses Participate in due diligence visits with clientsSupport quality compliance initiatives: Work cross functionally to perform gap assessments for global procedures, identifying compliance improvements and efficiencies Collaborate in procedural and process changes. Implement and drive the Compliance Improvement Plan initiative itemsSupport client facing communications and notifications Implement and drive the Compliance Improvement Plan initiativeOther ResponsibilitiesSupport close out of change controls and CAPAs resulted from Audits or inspections.Support training program related to Audits and inspectionsSupport Data compliance as requiredQualifications Bachelor's degree or 3+ years' related experienceExcellent working knowledge of GMPs, including interpretation and application of regulations across pharmaceuticals and biologics Strong communication skills, both orally and written. Strong organizational and time-management skills, with ability to work to timelines and meet project milestonesWorking ConditionsRegular office working conditionsPhysical RequirementsPersonal Protective Equipment must be worn as required

Keywords: Rentschler Biopharma, Inc., Worcester , Quality Assurance Compliance Associate III, Other , Milford, Massachusetts