Sr. Technical Complaints Specialist @ Novartis Consumer Health
Quality and compliance focused, enthusiastic professional with over 15 years of progressively responsible experience and documented results in the pharmaceutical industry. Strong technical background with versatile experience in managing complaints, conducting investigations, identifying root causes, implementing CAPAs, quality oversight of Third Party Organizations (TPO) and reviewing QC/method validations in accordance with USP and ICH guidelines. Highly dependable,
Quality and compliance focused, enthusiastic professional with over 15 years of progressively responsible experience and documented results in the pharmaceutical industry. Strong technical background with versatile experience in managing complaints, conducting investigations, identifying root causes, implementing CAPAs, quality oversight of Third Party Organizations (TPO) and reviewing QC/method validations in accordance with USP and ICH guidelines. Highly dependable, organized, and detail orientated individual consistently delivers quality results while meeting aggressive timelines. A collaborative team player strives to achieve the goals and objectives of the organization to improve quality and maintain company core values.
Sr. Technical Complaints Specialist @ Prepare complaint case reports in accordance with health authority requirements & SOPs.
Major Accountabilities: Assure quality and compliance by verifying product information and subject codes from Call Center during Initial Evaluation of complaint cases; analyze and identify potential trends in data related to product complaints; ensure accuracy, compliance and completeness of investigation results obtained from Third Party Organizations (TPO) while simultaneously managing aggressive timelines; ensure data integrity and prevent overdue complaint cases while reviewing and approving complaint investigations through effective relationship management with the TPOs; drive quality and compliance by verifying effective root cause analysis methodology; implement CAPAs and diligent follow up for CAPA Effectiveness related to complaints through quality oversight of the TPOs; and author Annual Product Quality Review (APQR-APR) complaint summaries for various consumer products. From May 2013 to Present (2 years 8 months) Senior Laboratory Auditor, QC Analytical Services and QC lab @ Reduced costs by $1 million annually by authoring IHRS protocols, reports, and audited IHRS projects
Met the targeted goal of producing four effective IHRS per month.
Improved quality and compliance by auditing method optimazations, cleaning/impurity method validations, vendor method transfers/qualifications, USP/Teva method equivalency studies and responses to regulatory agency deficiency letters. Delivered accurate and quality method validation reports by critiquing the final drafts. Met the deadlines of CAPA by collaborating laboratory investigation reports with supervisors. Harmonized SOP globally for Teva North America.
Delivered timeliness, quality, and accuracy by auditing Raw Materials, Finished Products/Stability testings and calibrations of instruments for QC lab.
Procured, maintained, and monitored reference standards usage for Quality Control laboratory. Complied to Drug Enforcement Agency (DEA) by compiling biannual inventory and end of year waste destruction each year. From July 2008 to February 2013 (4 years 8 months) Laborotory Auditor II @ Improved quality and compliance by auditing method optimizations, cleaning/API impurity method validations, vendor method transfers/qualifications, and USP/Teva method equivalency studies. Delivered accurate, quality method validation reports by reviewing the final drafts. Improved turn around time for CAPA by collaborated laboratory investigation report.
Met deadlines, provided quality andudited Raw Materials, Finished Products/Stability testings and Instrument Calibrations for QC lab.
Also procured, inventoried, and maintained all reference standards for QC lab. From July 2005 to July 2008 (3 years 1 month) Quality Control Laboraoty Auditor @ Reviewed and audited laboratory notebooks in Raw Materials, Finished Products/Stability, Robotics/Automation, and Instrument Calibrations for Quality Control to ensure strict compliance with USP, company SOPs and Test Methods. From November 2003 to July 2005 (1 year 9 months) Associate Scientist II @ Analyzed finished products, liquid ointment, transdermal systems and raw materials for content uniformity, dissolution, impurity, residues, water content, heavy metals, and other critical product specifications.
Achieved project timeliness by delivering quality testing results in accordance with USP, SOPs, and test methods for Analytical Control Lab.
Trained co-workers in raw material testing methods. From June 1991 to October 1996 (5 years 5 months) Chemist @ Prepared and tested soil/aqueous samples and maintained related testing records and organic extractions. Operation of AA, ICAP and Mercury analyzer and instrumental data review. From July 1988 to July 1991 (3 years 1 month)
B.S, Chemistry @ Michigan State University From 1984 to 1988 Kady Price is skilled in: CAPA, V&V, Software Documentation, Testing, Laboratory, 21 CFR Part 11, Organic Chemistry, Change Control, GxP, Regulatory Affairs, Computer System Validation, Chromatography, Quality System, Trackwise, UV/Vis
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