Charlene White's Location
Paterson, New Jersey, United States, United States
Charlene White's Contact Details
Charlene White work email
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About Charlene White
Experienced Managing Director with a demonstrated history of working in the medical device industry. Strong business development professional skilled in Operations Management, Medical Devices, Regulatory Requirements, Root Cause Analysis, and Management.
Charlene White Work Experience Details
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Managing DirectorQuality Promise, Llc Jan 2017 - Present
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Lead AuditorQuality Auditing Llc Jun 2017 - PresentMinneapolis, Mn, Us -
Contract Senior AuditorSqa Services, Inc. May 2014 - PresentAudit 3rd Party Suppliers
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ContractorThe Execu|Search Group Jun 2014 - May 2016New York, Ny, UsCorporate Complaints and CAPA-SME -
Manager, Quality AssuranceConvatec Sep 2013 - Apr 2014London, England, GbInterface with applicable departments to communicate CAPA project status.Create presentations to communicate progress to departments and senior leadership.Ensure effectiveness and efficiency of the CAPA system.Chairs the CAPA Review Board meetings and coordinates all CAPA system requirements per SOP. This includes the risk management of CAPA associated activities and communicating to senior management of any trends and significant CAPA items. Recommend and implement product quality and process improvements. Review and provide recommendations for written reports and supporting documentation for investigations, RCA and other related CAPA documentation. Support the CAPA Board and Users regarding the CAPA process, CAPA record content, and CAPA software.Interface with Regulatory agencies during periodic audits.Review CAPA trendsOversee and monitor timelines of CAPA system and metrics.Provide leadership with the CAPA review board to achieve quality goals.Interact with engineering, manufacturing and R & D personnel.Problem solve with root cause identification.Attend frequent meetings to communicate CAPA status -
Manager Of OperationsEnterix Inc, A Quest Diagnostics Company Sep 2012 - Aug 2013Secaucus, Nj, UsReview requirements to ensure timely delivery to our customers.Plan production operations, establishing priorities and sequences for products.Supervise, train and manage all operations personnel.Review production reports and resolve operational or manufacturing problems to ensure minimum costs and prevent operational delays.Develop or revise standard operating procedures and train/observe workers to ensure compliance with standards.Responsible for process validationsDevelop and manage manpower requirements based on forecasts.Supervise and manage all outsourced manufacturing and production.Primary liaison with vendors for on-time supply of quality product.Collaborate with internal QA personnel to manage and safeguard supply chain qualityAssist and monitor internal QA in the regular audits and to implant strong controls around vendors.Assess customer requirements, buying trends and make recommendations to customers’ purchasing department.Responsibility for manufacturing budgets and production results.Responsible for Employee Health & Safety.Manage Customer Service staffMember of senior management of EnterixMember of Management Review teamDeputy Management Representative -
Quality / Regulatory ManagerEnterix, A Quest Diagnostics Company May 2006 - Sep 2012Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements.Developed new hire and continuous training program.Developed internal and external supplier audits program.Developed Complaint and CAPA program.Developed plan and gap analysis for ISO 13485 certification.Developed Training plan for regulatory audits. Conducted mock audits.Overseer pre and post batch record, stability and validation protocol reviews.Conduct and train on internal discrepancy investigations through root cause analysis, associated with NCR’s, Complaints, and CAPA’s.Implement, revise and train on standard operating procedures to ensure compliance with standards.Evaluate and qualify product related suppliers. Monitor supplier performance via SCAR’s.Develop Internal and External Supplier schedules.Develop and present Quality Metrics for both Enterix US & Australia Sites.Manage Quality indicators, such as; Customer Complaints, non-conformances and CAPA’s.Head quarterly management review meetings as Management Representative.Liaison with FDA, ISO and Corporate Regulatory/Legal when required. Responsible for maintaining compliance to QSR and ISO 13485:2003.Quest Diagnostics Corporate Compliance liaison in reference to consent decree.Responsible for timely Corporate Integrity Agreement requirements with Independent Review Organization on behalf of FDA for Corporate Consent Decree.Managed Quality Consultants.Assisted with Operations department with Quality and Supplier concerns.Liaison with Corporate Compliance and Legal for Enterix concerns.Interaction with Accounting, Operations, Sales, and Marketing departments to ensure compliance.
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Senior Quality & Compliance ManagerSanofi-Aventis, Mar 2004 - Mar 2006Senior Quality & Compliance Manager (7/2005 – 3/2006Corporate QA liaison for third party affiliate for product concerns and resolution.Conduct external audit of third party affiliate complaint investigation process.Review and approve all manufacturing investigation summaries for complaint closure.Direct contact for sales force in regards to Urology product complaints and concerns.Review of all internal Pharmacovigilance MedWatch forms.Provided knowledge and written documentation of legacy Sanofi Product Complaint process for Kansas City transition.Quality Assurance Manager (3/2004 – 7/2005)Aid and assist in daily management of various Quality Assurance operational functions including the corporate SOP program and the Technical Product Complaints program.Supervise current staff in routine activities relating to the final review and disposition of Product Complaints.Interact with internal/external customers to facilitate complaint resolution.Create and distribute periodic reports.Ensure the internal QA website and various QA databases are maintained by coordinator.Received the Horizon Employee Excellence Program “Star Award” (8/25/04)
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Quality Assurance ManagerAlmedica Services Corp., Allendale, Nj Aug 2002 - Feb 2004Conducted root cause investigations and initiate corrective/ preventative action as necessary.Reviewed and maintain QS proceduresReview and approve Incoming Material Inspection documents and maintain database.Release drug from quarantine status for clinical shipments.Document & train shipping personnel for all initial clinical trial shipments. Respond to client questions pertaining to post production batch records.Managed 6 QA inspectors and 2 QA supervisors.Conduct Walk-Around Audits to ensure cGMP compliance and follow-up on observations.Conduct weekly QA departmental meetings and cGMP training.Review and approve change controls, temperature chart recorders.Interact with various departments for QA resolution.
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Quality Assurance Specialist IiiOrtec International, Inc. Apr 2001 - Jul 2002Review and update Complaint Handling and MDR reporting systemReview and maintain nonconformances with interim corrective action and disposition. Assist in failure investigations, relating to nonconformance’s for closure.Track corrective/preventative action for nonconformances.Generate weekly and monthly reports for status of nonconformances.Assist customer service for the receiving of customer complaints.Assist with batch record review and sign-off for closure.Update and maintain nonconformance database.Responsible for visual inspection of product prior to shipment.
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Quality Assurance — Complaint HandlingHowmedica Osteonics. A Division Of Pfizer May 1984 - Mar 2001Record and process product complaints received domestically and internationally in accordance with FDA guidelines. Review reports relative to the identity, quality, durability, reliability, safety, effectiveness, and I or performance of a device. Conduct root cause investigations and initiate corrective/ preventative action as necessary. Determine reportability under the Medical Device Regulation and Medical Device Vigilance. Generate reports and / or create a rationale for not reporting under Medical Device Regulation and Medical Device Vigilance.Regulatory Compliance - Sr. Release Officer (1987 - 2000) Release medical device history records for sterile and non-sterile products. Review device history records to ensure compliance to FDA regulations. Resolve product discrepancies with departmental supervisors, managers, engineers, and production planners. Responsible for data entry of new product complaints. Assist with product recalls, remedial actions, and recoveries. Conduct internal audit in various departments. Responsible for product destruction for Quality Assurance and review all scrap requests prior to destruction.Revise and prepare Regulatory Specifications and Standard Operation Procedures when applicable.Intermediate Inventory Control Clerk - (1984- 1987) Supervised approximately 30 people for two major internal inventory counts.Resolve stock failures with production planners. Process new product orders of rough and semi-finished stock. Resolve errors on daily pick-list utilizing the FIFO method. Maintain entries in daily log and AS400.
Charlene White Skills
Fda
Capa
Quality Assurance
Gmp
Validation
Medical Devices
Sop
Iso 13485
Quality System
Regulatory Requirements
Root Cause Analysis
Software Documentation
Change Control
Iso
Pharmaceutical Industry
Compliance
Customer Service
Internal Audit
Gdp
Complaint Management
Employee Training
Remediation
External Audit
Document Management
Batch Release
Complaint Investigations
Corrective Actions
Preventive Actions
Iso Management Representative
Consent Decree
Trackwise
Pilgrim
Siebel
Deviations
Gap Analysis
Sop Authoring
Mdrs
Team Leadership
Metrics Reporting
Management Review
Operations Management
Packaging Artwork
Supplier Quality Management
Third Party Inspection
Regulatory Interactions
Small Business Management
Small Business Marketing
Marketing
Design Control
Charlene White Education Details
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New York University
Frequently Asked Questions about Charlene White
What company does Charlene White work for?
Charlene White works for Quality Auditing Llc
What is Charlene White's role at the current company?
Charlene White's current role is Managing Director.
What is Charlene White's email address?
Charlene White's email address is ch****@****ics.com
What is Charlene White's direct phone number?
Charlene White's direct phone number is +121268*****
What schools did Charlene White attend?
Charlene White attended New York University.
What skills is Charlene White known for?
Charlene White has skills like Fda, Capa, Quality Assurance, Gmp, Validation, Medical Devices, Sop, Iso 13485, Quality System, Regulatory Requirements, Root Cause Analysis, Software Documentation.
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