Quality Assurance Compliance Associate III
Company: Rentschler Biopharma, Inc.
Location: Milford
Posted on: January 24, 2023
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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
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