BATCH RECORD COORDINATOR DOCUMENT CONTROL Summary Throughout work experience, I focused quality aspects business. I organized responsible individual good communication skills experience regulatory industry. Accomplishments GMP (21 GFR 111) Trainer Production staff. Designed implemented systems relating trending measures relating production statistics. Designed implemented compressed air testing production facilities. Specimen Processing Trainer Member Idea Team McKay-Dee Hospital Microsoft Office All Internet Research 60 wpm typing speed. Experience Company Name City State Batch Record Coordinator Document Control 02/2015 Current I responsible document control involving aspect production batch record master manufacturing record. Produce Batch Record order received. Creates Master Manufacturing Record new products. This includes specifications defined customer regulatory agencies, i.e. FDA GMP (21 CFR 111) TGA (Therapeutic Goods Administration regulatory body therapeutic goods Australia.) Makes modifications necessary existing Batch Records ensure changes properly approved documented. This includes formulation changes, deviations change controls Master Manufacturing Record. Maintains documents files relate production Batch Records (Master Formula, Master Manufacturing Record, Finished Product Testing Specifications), ensure changes properly documented (change controls). Review printed material included part finished product ensure claims made label consisted formula. Excellent communication skills ability interact levels within company. Self-starter comfortable working team environment individual projects. Effectively communicates areas company maintain accurate records. Company Name City State Quality Assurance Specialist 09/2013 02/2015 I responsible systems involving Quality Assurance Albion facilities. I oversee improve facility's current quality manufacturing functions. Designed, implemented update quality trending measures Albion's facilities. Trending measures include tracking material yields well costs. Measures published company wide I formalize summary data presented Executive staff. Designed implemented testing program testing particles, oil, water microbial levels compressed air system according ISO 8573. Currently Metrology training program. Upon completion, I design implement program inspection, calibration tracking instruments tools relating production according ISO 17025. Formal NSF GMP training trained employees GMP ISO 9001:2008 standards. Member Material Review Board. The Board reviews determines direction product disposition project planning. Direct inspection products ensure adherence established standards quality. Prepare, review organize quality assurance data documentation. Write, revise, review approve standard operating procedures facility work instructions. Inspect audit facility daily. Formal reviews published reviewed Production staff. Write, revise review master manufacturing records (MMR) quality control documents include batch records pertaining production lot material. Review batch records adherence Quality HACCP Plan. Provided direct involvement design implementation new procedures relating in-house projects develop improve manufacturing systems processes according GMP (21 CFR 111) ISO standards. Excellent communication skills ability interact levels within company. Self-starter comfortable working team environment individual projects. Supervisor: Kory Longhurst (801-725-7348) Okay contact Supervisor: Yes. Company Name City State Specimen Processor 06/2010 09/2013 Facilitates laboratory organization patient care ordering, preparing directing testing appropriate lab testing. Trained mentored new employees. Responsible accurately receiving, ordering, processing, labeling auditing specimens according established procedure. Recognize factors may affect testing outcomes, I take appropriate action solve problems, consistently documents solutions according established protocols. Trained maintained appropriate knowledge computer systems test ordering practices insuring specimens properly entered computer systems. Effectively communicates specimen collection handling requirements, providing service external internal customers. Performs documents quality assurance checks provide correction/maintenance. Identify opportunities continuous process improvement executes project conception, data collection implementation. Performs sterile specimen preparation techniques. Follows appropriate documentation protocol properly identify patients correctly labels samples. I assist testing. I attended completed Specimen Processing School atIHC. I many customer service duties area working Home Health Nurses, couriers, department Techs taking outside calls Hospitals, clinics Physician Offices. While Processor McKay-Dee, I member Idea Team. I participated, approved implemented process improvement ideas departments within laboratory. Company Name City State Claims Processor 05/2001 07/2002 Processed medical claims assured proper payment accordance benefit plan. Provided customer service plan benefits, provider networks available services. Resolved claim issues members providers. Company Name City State Rural Carrier TRC 06/2000 07/2001 Proficient areas mail delivery. Numerous duties include, limited to: maintaining personal vehicle use route, sorting casing mail according postal regulations. Maintaining proper forms regulations special handling mail, bundling mail, loading vehicle, delivery collecting mail parcels. Performing follow customers always maintaining complete organized records delivery. Maintained neat organized working area. Company Name City State Owner 09/1999 07/2012 Extensive experience Customer Service relating online sales marketing. Developed detailed ads accurately describe wide range products health supplements, cars home items. Worked one-on-one vendors wholesalers distribution products. Company Name City State Chemist 06/1997 09/1999 Tested environmental samples pesticides herbicides. Developed maintained quality assurance measures relation pesticide enforcement grant required laboratories. Determined type extent testing required ascertain quality samples submitted analyses. Analyzed interpreted test results order assist administration laws, regulations specifications relating pesticide formulations residues found. Made final decisions pertain chemical content individual samples. Prepared official reports may called upon testify court Commissioner. Experience using Gas Chromatography High Performance Liquid Chromatography. Company Name City State Customer Service Representative Claims Processor 04/1996 03/1997 Extensive training processing, analyzing adjudicating claims. Performed complete detailed follow-up inquiries providers, subscribers departments within Mountain State. Extensive experience urgent resolution problems research using available resources, whether inquiry received telephone, correspondence person. Experience using numerous databases knowledge ICD-9, CPT HCPC coding. Very versatile throughout workload able switch tasks immediately accuracy efficiency. Company Name City State Project Coordinator 10/1992 04/1995 Maintained accurate records pertaining productivity budgeting. Generated, researched developed effective methods locating people government, commercial academic clients. Researched, investigated located people using variety cost-effective methods include: searches national regional databases, telephone interviews library searches. Analyzed, wrote produced locator reports clients fully describe locations people methods used locate them. Extensive experience accessing analyzing credit reports. Company Name City State Chemist II 05/1990 05/1992 Direct work breakdown scheduling lab preparation, execution clean up. Maintained specific operating procedures insured successful prosecution court law. Performed numerous chemical procedures including TLC, HPLC, ELISA testing methods. Maintained records accountability samples, testing equipment various stages testing procedures. Education Currently Enrolled Accounting 2018 Champlain College City State Currently Enrolled Bachelor's Degree Chemistry 08/1992 Virginia tech City State B.A. Chemistry Job Related Training: Quality Assurance Specialist NSF 21 GFR 111 Course completion. Quality Assurance Specialist AirCheck Academy, Trace Analytics Corporation Course completion compressed air testing food grade facility according ISO 8573. Specimen Processing School Intermounatin Health Care June 2010 July 2011. Skills Regulatory Compliance Document Control Quality Assurance Auditor GMP ISO 9001 NSF Calibration Medical Coding Customer Service Databases Microsoft Office Sharepoint Process improvement Product Testing Project planning Research