Senior QA Specialist, Client Support
JSR Micro, Inc.
ERP
Senior Quality Assurance Specialist – Compliance
JSR Micro, Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Durham • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
ERP
About the role
- Serve as Quality lead for site Inspection Readiness activities
- Works with the Operations teams to continuously improvement of procedures and process controls
- Support Global Compliance as site host for Internal Audits, Client Audits and Regulatory / HA Inspections
- Supports the Internal Audit program, serving as site point of contact and Quality lead for all Internal Audits
- Coordinates discussions and corroborates with site SMEs to develop robust solutions and deliver comprehensive responses to client Audit observations
- Assists with coordination of activities and compilation of data to complete Annual Product Quality Reports (APQR)
- Supports the Quality Risk Management program
- Performs trending and routine monitoring proactively to identify potential compliance gaps and improvement needs
- Reviews / Approves Continued Process Verification (CPV) reports
- Conduct nonconformance investigations and write/review final reports
- Collaborates with Operations and Quality teams to identify and implement effective CAPAs
- Monitors effectiveness and expected impact on Compliance Metrics
- Establishes, Writes, and revises Standard Operating Procedures
- Assists with Quality related Training
Requirements
- BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries
- AS/AA acceptable with 7-10 years of relevant experience
- Minimum 7 years prior experience in the Pharmaceutical/Biotechnology industry
- thorough knowledge of Quality Systems, Quality Assurance, and Quality Operations
- solid knowledge of global GMP Quality and Regulatory requirements
- Minimum 5 Years experience in an FDA regulated Manufacturing facility
- Prior experience managing audits or internal inspection in a pharmaceutical environment
- Experience with Nonconformance reports: Deviations, Product Complaints, CAPAs
- Demonstrate sound leadership
- Ability to work professionally with others and facilitate positive interdepartmental interactions
- Demonstrate strong attention to detail and effective investigation, problem solving, and organizational skills
- Ability to properly prioritize tasks and manage time effectively
- Excellent written and verbal communication skills
- Ability to read, write, and proofread technical documents, investigations, regulatory documents, etc.
- Ability to compile and analyze data and information from multiple sources
- Ability to perform basic calculations and data assessment, simple statistics, graphing, plotting data
- Minimum intermediate proficiency with Microsoft Office Excel, Word, PowerPoint
- Intermediate proficiency with ERP and QMS systems required, such as SAP, TrackWise, and LIMS
Benefits
- annual bonus structure for all employees
- medical, dental, and vision coverage
- paid PTO and holidays
- 401K matching with 100% vesting
- employee recognition programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality SystemsQuality AssuranceQuality OperationsGMP QualityRegulatory requirementsNonconformance reportsCAPAsData analysisStatistical analysisProcess Verification
Soft skills
LeadershipInterdepartmental collaborationAttention to detailProblem solvingOrganizational skillsTime managementWritten communicationVerbal communicationFacilitationInvestigation
