Quality Engineer Manager
Resume:
Monica Andersen
Clifton, New Jersey 07011
***********@*****.***
EMPLOYMENT
Impax (Formely Corepharma)
November 3,2014 - Present
Complaint Manager
Leads effective and timely communication and appropriate escalation of quality issues based upon surveillance data. Participates in quality review and field action decisions. Communicated safety trends and recommends potential resolutions and /or actions. Supports and sometimes leads as Complaint Handling unit subject matter expert for regulatory inspection. Understand and implement the FDA compliant regulations for Drug and Devices. CAPA Management, Retain Samples Management. Host FDA Audits and DEA.
Therakos
September 1st, 2014- August 31st, 2014
Senior Quality Engineer (Consultant)
Lead complaint investigation teams
Dr Reddy’s Laboratory.July 15 2013 – August 11, e2014.
QA Manager, Product Complaints
Supervise two Complaint Analysts
Leads complaint handling and prepare process for Triage, SAN, Close out Complaints cases for Generics Drugs, Injectable, OTC
Manage contract company Call Center.
Responsible for identify and escalate potential Field Alert Reports
Implement Triggers words to facilitate the identification of Critical Complaints
Leads complaints investigations.
Ethicon, (Via Kaztronix) Sept 10, 2012- July13,2013.
Quality Engineer
Prepare and submit MedWatches and MedWatches Follow-Up.
Approve and Close out Complaints cases post-Investigation
Triage and received Product Complaints.
Sanofi-Aventis via!Gate-Patni April 2011 to September 2012
Compliant Analyst/ Assistant Manager of Operations
Leads complaint handling and prepares associated documentation for vigilance reporting, trending and signal detection. Collaborates with cross functional groups to drive process improvements and regulatory compliance. Ensures departmental policies and procedures are in place to deliver to company goals and objectives and that meet regulatory compliance requirements. Leads effective and timely communication and appropriate escalation of quality issues based upon surveillance data. Participates in quality review and field action decisions. Communicated safety trends and recommends potential resolutions and /or actions. Perform training to new Analysts in compliant processes
Merck, January 2011 to April 2011
Complaint Analyst, Contractor, Global Quality Complaint Management.
Responsible for creating, review and administrative closure of complaint files, 2nd level triage review of urgent cases, generation of consumer responses, group trainings, SOP maintenance, and oversight of all product complaint handling (product quality complaints, Adverse Events requiring investigations, and investigation status monitoring, and consumer contacts). Facilitates database management in Trackwise of all product complaints and the corresponding investigations. Collaborates with Medical Information and Pharmacovigilance teams in regards to the seriousness and urgency of complaint handling. Interprets MedWatch filed by consumer as received from FDA. Assures investigation reports received from Third Party Supplier and other investigating team sites are updated. Reviews investigations from Third Party and other Merck manufacturing sites on product complaints to assure the correct issues and type of investigation are properly addressed and performed respectively.
GlaxoSmithKline, June 18, 2001-December 2010
Regulatory Compliance R&D
Manages and maintains the Regulatory Compliance audit databases. Assists in the development and implementation of internal training programs, conducts Regulatory Compliance GMP/GCP Audits, Performed GMP training to the entire facility. Releases Clinical Trial Batches, provide consultancy in R&D Future Projects and. Implemented CARISMA and Trackwise systems and provide training for UK, USA and Latina sites.
Global Manufacturing Product Release Specialist
Prepare, issue and maintained Standard Operating Procedures, Prepare and maintained Quality Manuals for third party contractors. Performed Global Function of Releasing Product for Foreign and Domestic Markets. Provide training for new Contractors on GSK Release and Consumer complaint process. Prepare and issue Quality Control Specifications to GSK Sister sites and contractors. Performed Batch Record and sample product review of products manufactured by contractors prior to release. Enter production quantities in PRISM. Review, evaluates and maintained Product Consumer Complaint Processes. Follow-up on overdue complaint investigation responses. Compile and published Key Performance Indicators using Access and Excel to upper management.
Pure World Botanicals, August 1st, 2000-February 19th, 2001
Compliance Specialist
Created and maintained a Standard Operating Procedures Manuals for the company. Implemented in-house GMP Training for the entire company. Initiated a calibration program for the QC Laboratory; Created Specifications and assign Products codes. Implemented and maintaining the quarantine program. Assisted the QC/R&D laboratories creating out of the plant training. Performed Quality Audits in the Plant. Prepared plant equipment list and devised cross-referencing scheme.
TEVA Pharmaceuticals USA, 1988 - July 2000
Documentation Control-QA Technician
Created and maintained Standard Operating Procedures, Conducted SOP Training and maintain a Matrix for plant training. Created, Issued Batch Records performed final Batch Record Review (production and analytical folders). Participated in FDA and Quality Compliance Inspections of the Plant and was part of the Audit Response Team. Prepared and maintained a database for Corrective Actions and Consumer Complaints.. Assisted the Director of Operations to design and formulated Trend Analysis Reports for Budget, and Forecasting.
EDUCATION
Berkeley College, West Paterson, New Jersey
Bachelors in Sciences
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