Quality Assurance Specialist

Kelly **** Wilcox Salcido Ave, Bell, CA ***** 323-***-**** ************@*****.***

Objective

• To compliance satisfaction pursue growth knowledge and the with opportunity and a leading expertise. to organization make I aim a substantial to take and become on responsibilities and positive part of a impact team that where offer on the both I company’s can personal utilize my success. QA Education

BACHELOR OF SCIENCE 2014 UNIVERSITY OF PHOENIX

• • Major: Minor: Business Human Resources

Skills

• • • • Knowledge Oracle. Languages: A situations. Excellent well-organized Proficient team of English applicable player, quick with / Spanish. who MS learner computer Word, can Spoken who work PowerPoint, systems is with and not only little written. and Access, flexible or applications no supervision. Excel, but can and for multi-Acrobat Harmony task DC and Track Pro. work wise, under Wisdom, extreme and Experience

QUALITY ASSURANCE SPECIALIST AMEN CLINICS FEBRUARY 2022 – NOVEMBER 2022

• • • • • • • • • • Ensure Local Ensure all Manage Approve Maintain Revise Perform Inventory Liaison product Reporting Perform other Quality and BrainMD’s BrainMD’s with all Adverse Internal other applicable Certificates the of (internal Approve SAER) Customer Dietary company’s Regulations. duties Event Quality portal. internal Dietary regulations. product of Supplements, of as Standard Service, Analysis Reports assigned, product Audit Supplement practices Quality of other and for Operating quarantine, Dietary required, and all record when comply departments, incoming and Food Supplements necessary, Procedures keeping. Food or with Products. storage, directed shipments Products the and report shipping, current (and by the SOPs)upper comply General Food from events Good . return Management. Contract Products with Manufacturing to Manager the and all FDA Manufactures. disposal applicable records. to via record Serious Practices processes. Federal, and Adverse investigate (cGMP) State Event and and QA ASSOCIATE ARMATA PHARMACEUTICALS DECEMBER 2019 – OCTOBER 2020

• • • • • • • • • • • • • • Supports Document Continuous Review, templates, Execute/Establish Archival Revise, Assurance Perform departments. Partner colleagues (Review Review Maintain Complete Maintain Other cGMP) duties maintain, Batch documentation and with approval, Quality of support floor employees maintenance and monthly Change SOPs. and in controlled Improvement. Good as Production ensuring maintain Records. books other assigned. audits QMS and Clinical and Requests, SOP training controlled and implement documents. revision improvement high of of accurate and and and Quality laboratory critical Practices quality Forms release Training, Facilities, records of documents. and raw quality Management Standard audit products (raw GCP)notebooks. projects. electronic and material CAPA, Quality materials. for system . employee’s Operating all and Change suppliers, System departments. Control, and documents compliance paper-Management files. Procedures (Clinical QMS) contract based including with programs, Operations, filing manufacturers, (current Risk SOPs) Quality systems. Assessment, including specifications, Good and Manual, other Manufacturing and but Validation operations internal and not forms, limited Quality GMP and Practices to MFG COMPLIANCE COORDINATOR TEVA PARENTERAL MEDICINES JUNE 2013 – JANUARY 2018

• • • • • • • • • Responsible Manufacturing Projected Provide and Control Collaborate proposed documents Coordinate initiation Collaborate processing Assess requirements. Contribute Collaborate Assist TPM Technical Change Management guidance Management, to changes. Business to of and the with with with implementation. for Change meetings Assures Control Documents tasks take initiating Lead internal appropriate TPM during Assess Forecasts, appropriate associated team. Controls. with Management no activities including and the customers and major potential CAPA’s for projects review Department coordinating Standard process with compliance to action the and ensure compliance Changes and associated (various the Operations, in revising Operating to approval electronic/optimization Management mitigate. compliance Change issues providing tasks with SOP’s. issues Planning, of Procedures, and due Controls manual the the that with in Change activities to to Change Change compliance Change establish may RAMP, cGMP, workflow for and Control create scale-Controls Control within Control. FDA, Validation, applicable priorities, with up/of adverse expertise and the processes the among scale-TEVA Manufacturing/other Change regulations. Quality, deadlines impact down, Corporate the as regulatory and required. various Control create/RA) on system. and processes on Policies, Change stakeholders System tracking agency revise the TPM or from for

• Meet Corporate Objectives.

ASEPTIC FILLING OPERATOR 1 TEVA PARENTERAL MEDICINES MAY 2000 – JUNE 2013

• • • • • • • • Equipment operation Performed testing, inspection, Accurately documentation. Performed Completed Maintain Ensured Manufacturing Completed performed products aseptic of completed ISO pre-assigned tasks collect changeovers all Practices 7-manufacturing machinery technique as line manufactured samples headspace assigned training clearance, batch across and in for on record in on Safety ISO verification, a various component a multiple label time consistent in timely 5, accordance documentation, 6, Policies. to verification, and QC maintain manner. lines, programs. 7. visual monitor basis sanitization with to inspection training perform minimize filled all Standard appropriate product compliance (in-cleanroom to contamination process Operating reduce PM logbook by with volume finished and conducting Procedures, procedures equipment)entries in (product employing ISO 5 and in-and current process and, defective GMP line ISO SPC policies. set-6 Good technique) areas. visual ups, units. MFG TECHNICIAN ALPHA THERAPEUTIC CORP JUNE 1998 – SEPTEMBER 1999

• • • • • • Responsible assemble, Certified Inspection Familiar Operation Follow SOP with for operation of of and inspection for cleaning vials, loading trouble cGMP stoppers, and and and guidelines. and shooting, inspection unloading loading operations and filling operation Amsco of pasteurizer, DUS of equipment. Autoclave the 550 cleaning Gilowy and testing 160 Sterilizer. equipment. and Syringe of sanitization DFA, filling 10 Micron, of machine filling Millipak, equipment and Huber and Millipore such Washer. as filters. References

Available upon request.

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