Experience

ADMA Biologics, Inc.

• United States
• Biotechnology Research
• 100 - 200 Employee

• Supplier Quality Assurance

  • Nov 2019 - Present



Compounding Docs, Inc.

• Boca Raton, FL

• Quality/Compliance/Process Improvement Coordinator

  • Apr 2019 - Nov 2019

  •Ensure that all aspects of the operations comply with appropriate legal and regulatory requirements. •Create and maintain the environmental monitoring program to demonstrate the control of microorganisms within critical areas to ensure the safety and efficacy of pharmaceuticals. •Quality oversight for aseptic processes of personnel qualification. •Recommend, obtain approval for and monitor corrective action to be undertaken if problems are identified. •Initiate CAPAs, change… Show more •Ensure that all aspects of the operations comply with appropriate legal and regulatory requirements. •Create and maintain the environmental monitoring program to demonstrate the control of microorganisms within critical areas to ensure the safety and efficacy of pharmaceuticals. •Quality oversight for aseptic processes of personnel qualification. •Recommend, obtain approval for and monitor corrective action to be undertaken if problems are identified. •Initiate CAPAs, change controls, and any other product related documents ensuring adequate levels of documentation are satisfactory and compliant to existing procedures. •Support, write, review, and enforce Standard Operating Procedures (SOPs). •Maintain BOP licensing for resident and all non-resident states. •Report any misconduct, suspicious or unethical activities to Operations. •Monitor and resolve problems that address the following key functions: -Program evaluation -Risk Management -Utilization Review -Patient Care Evaluation -Administration policies and procedures -Management of human resources -Management of the environment of care -Surveillance, prevention, and control of infection. •Conduct Performance and Quality Improvement studies as necessary and maintain records. •Prepare quarterly reports followed by a meeting for review with the Governing Body. •Evaluate pharmacy compliance with all laws and regulations; ensure that the pharmacy meets or exceeds accreditation standards; and evaluate ‘’best practices’’ in all departmental activities. •Participate in inspections conducted by authorized inspection agencies. •Participate in pharmacy committees when requested. •Participate and conduct in in-service training education programs provided by the pharmacy. •Pursue continuing education programs appropriate to job responsibilities. Show less •Ensure that all aspects of the operations comply with appropriate legal and regulatory requirements. •Create and maintain the environmental monitoring program to demonstrate the control of microorganisms within critical areas to ensure the safety and efficacy of pharmaceuticals. •Quality oversight for aseptic processes of personnel qualification. •Recommend, obtain approval for and monitor corrective action to be undertaken if problems are identified. •Initiate CAPAs, change… Show more •Ensure that all aspects of the operations comply with appropriate legal and regulatory requirements. •Create and maintain the environmental monitoring program to demonstrate the control of microorganisms within critical areas to ensure the safety and efficacy of pharmaceuticals. •Quality oversight for aseptic processes of personnel qualification. •Recommend, obtain approval for and monitor corrective action to be undertaken if problems are identified. •Initiate CAPAs, change controls, and any other product related documents ensuring adequate levels of documentation are satisfactory and compliant to existing procedures. •Support, write, review, and enforce Standard Operating Procedures (SOPs). •Maintain BOP licensing for resident and all non-resident states. •Report any misconduct, suspicious or unethical activities to Operations. •Monitor and resolve problems that address the following key functions: -Program evaluation -Risk Management -Utilization Review -Patient Care Evaluation -Administration policies and procedures -Management of human resources -Management of the environment of care -Surveillance, prevention, and control of infection. •Conduct Performance and Quality Improvement studies as necessary and maintain records. •Prepare quarterly reports followed by a meeting for review with the Governing Body. •Evaluate pharmacy compliance with all laws and regulations; ensure that the pharmacy meets or exceeds accreditation standards; and evaluate ‘’best practices’’ in all departmental activities. •Participate in inspections conducted by authorized inspection agencies. •Participate in pharmacy committees when requested. •Participate and conduct in in-service training education programs provided by the pharmacy. •Pursue continuing education programs appropriate to job responsibilities. Show less



KRS Global Biotechnology 503B State-of-the-Art Facility

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance

  • Dec 2017 - Apr 2019

  • Ensure that all aspects of the operations comply with cGMP legal and regulatory requirements. • Review documentation associated with a given product. • Coordinate and perform batch record disposition of product and raw materials. • Review/approve manufacturing and QC related documents for batch record disposition. • Review/approve QC data in support of testing performed for batch record disposition. • Participate in “On the Floor” Manufacturing activities, such as Quality… Show more • Ensure that all aspects of the operations comply with cGMP legal and regulatory requirements. • Review documentation associated with a given product. • Coordinate and perform batch record disposition of product and raw materials. • Review/approve manufacturing and QC related documents for batch record disposition. • Review/approve QC data in support of testing performed for batch record disposition. • Participate in “On the Floor” Manufacturing activities, such as Quality Oversight for Aseptic Process Validation and Operator Qualification activities and “Real Time” Batch Record Review, etc. • Initiate, review, and support deviations, CAPAs, change controls, and any other product related documents ensuring adequate levels of documentation are satisfactory and compliant to existing procedures. • Coordinate activities associated with CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish notes and action items from meetings; provide support to the investigation process and follow-up to assure timely discrepancy closures. • Perform independent quality evaluation of deviation reports including root cause analysis, cause/preventive action identification, CAPA effectiveness check and trending. • Support, write, and review Standard Operating Procedures (SOPs) and associated Work Procedures (WPs) and Forms (FRMs) Quality Risk Assessments (QRAs), Quality Plans, specifications, Batch Production Documents (BPDs), Manufacturing Production Documents (MPDs), or other documentation, as needed. • Responsible for maintenance and control of Master File Documents • Issuance of CAPAs/Deviation/Change Control number and logs. • Assist with Vendor Supplier Audits, FDA, BOP audit/inspections.

• cGMP Sterile Compounding Technician

  • Jul 2016 - Dec 2017

  Sterile Compounding of manufactured drugs, adhering to cGMP regulations and USP 797. Compounding and dispensing of vial injections, cartridges, pre-filled syringes, IV admixtures, etc. Same day lab testing before filteration and dispensing occurs. Bubble point testing for each compound. Maintain logs and batch records. Quarantine storage of drugs. GFT testing and EM testing. Media fills every 6 months per SOP. Autoclaving and depyrogenation. PH adjustments. Use of dispensing machinery such as… Show more Sterile Compounding of manufactured drugs, adhering to cGMP regulations and USP 797. Compounding and dispensing of vial injections, cartridges, pre-filled syringes, IV admixtures, etc. Same day lab testing before filteration and dispensing occurs. Bubble point testing for each compound. Maintain logs and batch records. Quarantine storage of drugs. GFT testing and EM testing. Media fills every 6 months per SOP. Autoclaving and depyrogenation. PH adjustments. Use of dispensing machinery such as the Cozzoli, Colonar, Dara, repeater pumps, and dosing pumps.



Patient Care America

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Compliance Coordinator/Licencing/Auditor

  • Jan 2015 - Aug 2016

  Analysis reports. Comply and observe legal, ethical, and corporate guidelines. Maintain HIPPA compliance, promote confidentiality. And report violations to the director of operations. Maintain knowledge of regulatory requirements, new pharmacy practices, and board regulatory changes. Maintain BOP licensing/renewals/relocation licensing for all US states. Submit PDMP reports on a daily, weekly, and monthly basis. Process internal audits, as well as incoming audits from outside insurance… Show more Analysis reports. Comply and observe legal, ethical, and corporate guidelines. Maintain HIPPA compliance, promote confidentiality. And report violations to the director of operations. Maintain knowledge of regulatory requirements, new pharmacy practices, and board regulatory changes. Maintain BOP licensing/renewals/relocation licensing for all US states. Submit PDMP reports on a daily, weekly, and monthly basis. Process internal audits, as well as incoming audits from outside insurance companies. Run specific pharmacy prescription related reports on PK software. Quality assurance of drugs made, by catching any errors before they leave the door.

• Sterile IV Tech / Non-Sterile Compounding

  • Jan 2015 - Jul 2016

  Sterile IV admixtures - IDPN/IPNs. Adhere to procedures as outlined in USP 797 and per SOPs. Inventory. Use of CPR+. Maintain temperature, humidity, and cleaning logs. GFT testing. Annual training. Non-Sterile Compounding of creams, sprays, capsules, ointments, suspensions, etc. Use of PK software to create labels, create logs and worksheets, maintain inventory, etc. Maintain electronic logs of scale calibrations, temperature, humidity, and cleaning. QA for capsules.



Meds Direct RX

• United States

• Non-Sterile Compounding Technician

  • Sep 2014 - Jan 2015

  Set up mock Compounding area. Create SOPs for newly upcoming compounding pharmacy. Help out with inbound patient calls regarding insurance coverage and payments. Set up PK software by inputting drug inventory, new formulations, etc Set up mock Compounding area. Create SOPs for newly upcoming compounding pharmacy. Help out with inbound patient calls regarding insurance coverage and payments. Set up PK software by inputting drug inventory, new formulations, etc



KRS Global Biotechnology 503B State-of-the-Art Facility

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sterile Compounding Technician

  • Mar 2014 - Sep 2014

  Sterile Compounding of vitamin injections, HCG, trimix, etc. Glassware autoclaving. Bubble point filter testing. Maintain temperature and cleaning logs. Crimping and labeling of vials. GFT testing and media fills. Non sterile Compounding of veterinary chemotherapy drugs in a germ-free hood. Hormone replacement compounds. Creams, ointments, capsules, tablets, troches, etc. QA calculations for capsules. Sterile Compounding of vitamin injections, HCG, trimix, etc. Glassware autoclaving. Bubble point filter testing. Maintain temperature and cleaning logs. Crimping and labeling of vials. GFT testing and media fills. Non sterile Compounding of veterinary chemotherapy drugs in a germ-free hood. Hormone replacement compounds. Creams, ointments, capsules, tablets, troches, etc. QA calculations for capsules.



Skip's Pharmacy

• United States

• Lead Compounding Tech / Mgr Asst

  • May 2012 - Mar 2014

  Compound creams, ointments, troches, chewies, lozenges, capsules, ear drops, eye drops, gels, supplements, and solutions. LDN (low dose naltrexone) capsules. QA calculations for capsules. Make concentrations for use in compounds. Assist manager with staff. Assign formula worksheets to technicians. Supervise staff in the absence of manager. Use of Exempt Rx software. Compound creams, ointments, troches, chewies, lozenges, capsules, ear drops, eye drops, gels, supplements, and solutions. LDN (low dose naltrexone) capsules. QA calculations for capsules. Make concentrations for use in compounds. Assist manager with staff. Assign formula worksheets to technicians. Supervise staff in the absence of manager. Use of Exempt Rx software.



Publix Pharmacy

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacy Technician

  • Oct 2010 - May 2013

  Fill prescriptions, process new prescriptions and refills, bill insurances, maintain inventory, data entry, cashier, receive drugs and supplies and check against invoices. Use of McKesson Rx Software. Fill prescriptions, process new prescriptions and refills, bill insurances, maintain inventory, data entry, cashier, receive drugs and supplies and check against invoices. Use of McKesson Rx Software.