Karen Martin Email and Phone Number
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A detail-oriented Quality Assurance Associate Director in biotech and gene therapy development with strong technical expertise and a diverse skill set with over 25 years of experience in quality assurance, quality control, & manufacturing operations, who strives to create strong working relationships with client groups and thrives in a fast-paced setting. Focused individual as well leader with as many as 15 direct reports possessing excellent decision-making, communication & writing skills, comfortable working in a wide range of disciplines seeking a quality assurance position in a clinical or commercial setting.
Editas Medicine
View- Website:
- editasmedicine.com
- Employees:
- 232
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External Quality Assurance ManagerEditas MedicineLongmont, Co, Us
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Associate Director Of Corporate Quality AssuranceEditas Medicine Jun 2021 - PresentCambridge, Massachusetts, Us
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Quality Assurance SpecialistAvexis, Inc. / Novartis Gene Therapies Aug 2019 - Jun 2021Basel, Baselstadt, Ch -
Senior Quality Assurance SpecialistNantcell / Immunitybio / Etubics Sep 2018 - Aug 2019• Support start-up activities for clinical-phase manufacturing of gene therapy / immunotherapy products (tumor-associated antigens & neoepitope vaccines) including: Aseptic Media Fill Challenges, Smoke Studies, Clean Room Qualification, Equipment Commissioning, Cleaning Effectiveness and Changeover Studies and review of IND• Establish Quality Systems for Supplier Quality Management, Raw Material Item Request, Raw Material Specifications, Raw Material testing, control and release, Deviation, CAPA, Document Management, Asset Request, URSs and Equipment Calibration and Maintenance and associated work order instructions• Support of Process Development Tech Transfer, Characterization studies and Analytical Development• Support of Viral Seed Stock Laboratory design and implementation• Utilize Risk Management approach to prioritize implementation of Quality Systems throughout start-up activities
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Senior Quality Assurance SpecialistRezolute, Inc. Nov 2017 - Aug 2019 Ensure GxP work at Rezolute and contract manufacturing facilities are compliant with regulations by providing quality oversight of Quality Systems including: batch record review and product disposition, change control, CAPA, deviations, document and records management, Supplier Quality, Training, audits, OOS/OOT investigations, validation of analytical methods
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Senior Quality Assurance SpecialistKbi Biopharma May 2016 - Nov 2017Durham, North Carolina, UsQuality Assurance Senior Specialist QA support of contract manufacturing of pre-clinical, clinical and commercial products Compliance review and approval of Batch Records, Solution Preparation Records, Standard Operating Procedures, Deviations, CAPAs, Change Controls and Material Specifications Lead changeover activities and continuous improvement on the changeover system Coordinate with clients for resolving questions and issues regarding executed batch records Inspection and release of raw materials Participate in regulatory and client inspections -
Quality AssuranceW. L. Gore & Associates May 2014 - May 2016Quality Assurance Professional QA support of design control and commercial manufacturing activities including: Change controls, equipment and process validations, nonconformance investigations, CAPAs Participated in process mapping for continuous improvement of Quality Systems and root cause analysis of nonconformance investigations Transformation of Quality Systems including Nonconformance, CAPA and Change Control o Plant champion for new nonconformance system providing expertise and training for manufacturing operators and quality associates Lead role supporting Combination Product project to implement quality system changes and establish infrastructure for 21 CFR Part 4 compliance for combination products including coated vascular grafts, endovascular and interventional deviceso Led Quality Unit team to implement procedures and systems to support Quality oversight for cleanroom manufacturing and quality control inspections Conducted internal audits ensuring compliance to site procedures and regulatory requirements
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Quality SpecialistAmgen May 2005 - Apr 2014Thousand Oaks, Ca, UsDirect on-the-floor support of manufacturing, providing timely risk-based decision making to maintain compliance during clinical & commercial manufacturing of biologicsQA owner of Nonconformance investigations and CAPAsSupport OE and Lean initiativesBatch record review of Manufacturing Procedures, log review & auditsBatch record review & Good Documentation Practices SME (Subject Matter Expert) -
Senior Quality AssociateAmgen May 2005 - Mar 2010Thousand Oaks, Ca, UsBatch Record reviewEquipment Use Record Log review and AuditsNonconformance investigationsCAPAs and Root Cause AnalysisSME of Good Documentation Practices
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Raw Material SupervisorSandoz Oct 2003 - Apr 2005Basel, Basel-Stadt, ChSchedule, coordinate, & organize raw material testing for ~250 productsApproval of raw material data for release to ManufacturingLead investigation of Laboratory Inquiry and InvestigationsWrite planned and unplanned deviationsAssist in Cleaning Validation inquiries and investigations as 2nd shift support
Karen Martin Skills
Karen Martin Education Details
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Dickinson CollegeChemistry
Frequently Asked Questions about Karen Martin
What company does Karen Martin work for?
Karen Martin works for Editas Medicine
What is Karen Martin's role at the current company?
Karen Martin's current role is External Quality Assurance Manager.
What is Karen Martin's email address?
Karen Martin's email address is us****@****ast.net
What is Karen Martin's direct phone number?
Karen Martin's direct phone number is +130374*****
What schools did Karen Martin attend?
Karen Martin attended Dickinson College.
What are some of Karen Martin's interests?
Karen Martin has interest in Social Services.
What skills is Karen Martin known for?
Karen Martin has skills like Quality Assurance, Gmp, Change Control, Fda, 21 Cfr Part 11, Biotechnology, Root Cause Analysis, Sop, Lims, Quality System, Gxp, Aseptic Processing.
Who are Karen Martin's colleagues?
Karen Martin's colleagues are Frank Panaccio, Dana Larkin, Sarah Minich, Jimit Raghav, Andrew M. Davenport, Kuldeep Desai, Atti English.
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